Trial Outcomes & Findings for Physiologic Effects of Steroids in Cardiac Arrest (NCT NCT02790788)

Results Overview

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

Results posted on

2021-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Steroids Group Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock.	Control Group Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase. Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock.
Overall Study STARTED	46	54
Overall Study COMPLETED	46	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physiologic Effects of Steroids in Cardiac Arrest

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Steroids Group n=46 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock.	Control Group n=54 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase. Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock.	Total n=100 Participants Total of all reporting groups
Age, Continuous	70.1 Years STANDARD_DEVIATION 19.2 • n=5 Participants	73.2 Years STANDARD_DEVIATION 12.3 • n=7 Participants	72.1 Years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Greece	46 participants n=5 Participants	54 participants n=7 Participants	100 participants n=5 Participants
Body Mass Index	27.5 kg/m^2 STANDARD_DEVIATION 8.8 • n=5 Participants	27.2 kg/m^2 STANDARD_DEVIATION 5.9 • n=7 Participants	27.4 kg/m^2 STANDARD_DEVIATION 7.3 • n=5 Participants
Hypertension	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Coronary Artery Disease	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Diabetes	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Cardiac Conduction Disturbances	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Cardiac Arrhythmia	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Valvular Heart Disease	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Peripheral Vascular Disease	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Other Comorbidity	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Hospital Admission Cause [Medical]	21 Participants n=5 Participants	36 Participants n=7 Participants	57 Participants n=5 Participants
Pre-arrest Hospital Stay (days)	15.4 Days STANDARD_DEVIATION 24.6 • n=5 Participants	10.6 Days STANDARD_DEVIATION 17.2 • n=7 Participants	12.8 Days STANDARD_DEVIATION 21.0 • n=5 Participants
Cardiac Arrest Cause: Hypotension	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Cardiac Arrest Cause: Myocardial Ischemia	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Cardiac Arrest Cause: Homeostatic Disorder	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Cardiac Arrest Cause: Arryhthmia	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Cardiac Arrest Cause: Other	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Cardiac Arrest Cause: Respiratory Failure	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC).

Outcome measures

Outcome measures
Measure	Steroids Group n=46 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=54 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).	78.4 mmHg Standard Deviation 21.3	75.1 mmHg Standard Deviation 21.4

PRIMARY outcome

Timeframe: Time points of measurement: 20 min after ROSC.

Population: DATA COULD NOT BE COLLECTED; REASON: A CENTRAL VENOUS BLOOD SAMPLE COULD NOT BE CONSISTENTLY OBTAINED AT 20 MIN AFTER RETURN OF SPONTANEOUS CIRCULATION, BECAUSE A CENTRAL VENOUS CATHETER WAS NOT IN PLACE ON MOST OCCASIONS; THE DATA MONITORING COMMITTEE RECOMMENDED THAT THIS SPECIFIC TIME POINT BE EXCLUDED FROM THE ANALYSIS.

Results on early postresuscitation central venous oxygen saturation (%) are provided for the first, pre-specified time point of measurement, I.e., 20 min after the return of spontaneous circulation (ROSC). Actually, and exclusively for this particular measurement, reasons for the failure of consistent data collection are given below.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Time points of measurement: 4 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 7 PATIENTS OF THE STEROIDS GROUP AND FROM 7 PATIENTS OF THE CONTROL GROUP, BECAUSE THESE PATIENTS DIED WITHIN LESS THAN 4 HOURS AFTER ROSC.

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=39 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=47 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).	83.9 mmHg Standard Deviation 18.1	78.9 mmHg Standard Deviation 15.6

PRIMARY outcome

Timeframe: Time points of measurement: 4 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 17 PATIENTS OF THE STEROIDS GROUP AND FROM 32 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE PATIENTS DIED WITHIN LESS THAN 4 HOURS AFTER ROSC, OR BECAUSE THEY STILL DID NOT HAVE A CENTRALVENOUS CATHETER IN-PLACE, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.

Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=29 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=24 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).	67.4 Percent Hemoglobin Concentration Standard Deviation 10.2	56.8 Percent Hemoglobin Concentration Standard Deviation 22.7

PRIMARY outcome

Timeframe: Time points of measurement: 24 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 11 PATIENTS OF THE STEROIDS GROUP AND FROM 16 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=35 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=38 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	79.9 mmHg Standard Deviation 16.0	81.9 mmHg Standard Deviation 15.2

PRIMARY outcome

Timeframe: Time points of measurement: 24 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 12 PATIENTS OF THE STEROIDS GROUP AND FROM 20 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.

Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=34 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=34 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	71.1 Percent Hemoglobin Concentration Standard Deviation 8.5	70.1 Percent Hemoglobin Concentration Standard Deviation 8.3

PRIMARY outcome

Timeframe: Time points of measurement: 48 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 17 PATIENTS OF THE STEROIDS GROUP AND FROM 19 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 48 HOURS AFTER ROSC.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=29 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=35 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	80.2 mmHg Standard Deviation 10.0	84.2 mmHg Standard Deviation 13.6

PRIMARY outcome

Timeframe: Time points of measurement: 48 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 18 PATIENTS OF THE STEROIDS GROUP AND FROM 22 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=28 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=32 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	73.3 Percent Hemoglobin Concentration Standard Deviation 8.0	70.5 Percent Hemoglobin Concentration Standard Deviation 6.5

PRIMARY outcome

Timeframe: Time points of measurement: 72 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 19 PATIENTS OF THE STEROIDS GROUP AND FROM 20 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 72 HOURS AFTER ROSC.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=27 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=34 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	85.2 mmHg Standard Deviation 11.6	84.7 mmHg Standard Deviation 14.5

PRIMARY outcome

Timeframe: Time points of measurement: 72 hours after ROSC.

Population: DATA COULD NOT BE COLLECTED FROM 19 PATIENTS OF THE STEROIDS GROUP AND FROM 24 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=27 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=32 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	72.5 Percent Hemoglobin Saturation Standard Deviation 9.5	70.4 Percent Hemoglobin Saturation Standard Deviation 7.1

SECONDARY outcome

Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

Population: REASONS FOR MISSING DATA RELATIVE TO TOTAL POPULATION: 1) PATIENT DEATH; 2) NON-ADHERENCE TO PROTOCOL. RVEDA / LVEDA WAS MEASURED AT LEAST ONCE AT 12 / 72 HOURS POST-ROSC IN 42 PATIENTS (20 CONTROL, N=20). FOR EACH ONE OF THE 2 VARIABLES AND TIME POINTS, THE NUMBER OF PATIENTS STUDIED IS =\< 22 FOR THE STEROIDS GROUP AND =\< 20 FOR THE CONTROL GROUP.

Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=22 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=20 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography. LVEDA within 12 hours after ROSC	23.1 cm^2 Standard Deviation 9.1	22.8 cm^2 Standard Deviation 8.2
Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography. RVEDA within 12 hours after ROSC	12.1 cm^2 Standard Deviation 4.3	13.0 cm^2 Standard Deviation 4.0
Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography. LVEDA at 72 hours after ROSC	23.1 cm^2 Standard Deviation 7.9	18.5 cm^2 Standard Deviation 2.9
Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography. RVEDA at 72 hours after ROSC	14.5 cm^2 Standard Deviation 3.7	12.6 cm^2 Standard Deviation 4.1

SECONDARY outcome

Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

Population: Reasons for missing data relative to total population: 1) patient death within 72 hours after ROSC; and 2) non-adherence to protocol. At 72 hours after ROSC, data was not collected from some of the aforementioned patients due to death or because transesophageal echo for the measurement of RVEF was not repeated.

Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=27 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=29 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Left and Right Ventricular Ejection Fraction (%) by Echocardiography. RVEF within 12 hours after ROSC	41.7 Percentage Standard Deviation 8.7	42.7 Percentage Standard Deviation 9.3
Left and Right Ventricular Ejection Fraction (%) by Echocardiography. LVEF at 72 hours after ROSC	45 Percentage Standard Deviation 11.8	50 Percentage Standard Deviation 9.4
Left and Right Ventricular Ejection Fraction (%) by Echocardiography. LVEF within 12 hours after ROSC	42.3 Percentage Standard Deviation 14.1	45.9 Percentage Standard Deviation 13.2
Left and Right Ventricular Ejection Fraction (%) by Echocardiography. RVEF at 72 hours after ROSC	42.8 Percentage Standard Deviation 8.4	44.7 Percentage Standard Deviation 7.1

SECONDARY outcome

Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

Population: Reasons for missing data relative to the total study population were 1) patient death within 72 hours after ROSC; and 2) non-adherence to protocol. Within 12 hours after ROSC, data were obtained from 43 patients (control, n=22). At 72 hours after ROSC, data could not be obtained from all the aforementioned patients, because some of them had died.

Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) "longitudinal" (or anteroposterior) diameter to the LV "transverse" (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=21 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=22 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Eccentricity Index by Echocardiography. End-diastolic ECCI within 12 hours after ROSC	1.2 ECCENTRICITY INDEX Standard Deviation 0.3	1.3 ECCENTRICITY INDEX Standard Deviation 0.3
Eccentricity Index by Echocardiography. End-systolic ECCI within 12 hours after ROSC	1.3 ECCENTRICITY INDEX Standard Deviation 0.3	1.3 ECCENTRICITY INDEX Standard Deviation 0.3
Eccentricity Index by Echocardiography. End-diastolic ECCI at 72 hours after ROSC	1.2 ECCENTRICITY INDEX Standard Deviation 0.2	1.3 ECCENTRICITY INDEX Standard Deviation 0.3
Eccentricity Index by Echocardiography. End-systolic ECCI at 72 hours after ROSC	1.2 ECCENTRICITY INDEX Standard Deviation 0.3	1.3 ECCENTRICITY INDEX Standard Deviation 0.4

SECONDARY outcome

Timeframe: Time points of measurement: 4 hours after ROSC.

Population: REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 4 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.

RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=14 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=11 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	4.9 L/min Standard Deviation 1.0	5.0 L/min Standard Deviation 2.0

SECONDARY outcome

Timeframe: Time points of measurement: 24 hours after ROSC.

Population: REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 24 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.

Results are provided for CO at 24 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=26 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=32 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.6 L/min Standard Deviation 1.6	5.4 L/min Standard Deviation 1.2

SECONDARY outcome

Timeframe: Time points of measurement: 48 hours after ROSC.

Population: REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 48 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.

Results are provided for CO at 48 hours after ROSC

Outcome measures

Outcome measures
Measure	Steroids Group n=27 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=31 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8 L/min Standard Deviation 1.6	5.7 L/min Standard Deviation 1.3

SECONDARY outcome

Timeframe: Time points of measurement: 72 hours after ROSC.

Population: REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 72 HOURS AFTER ROSC; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.

Results are provided for CO at 72 hours after ROSC.

Outcome measures

Outcome measures
Measure	Steroids Group n=27 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=31 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8 L/min Standard Deviation 1.8	5.6 L/min Standard Deviation 1.3

SECONDARY outcome

Timeframe: Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.

Population: For the first 6 hours after ROSC, data was collected from 74 patients (Controls, n=40); data was not collected from 26 patients (Controls, n=14), because of "early" death, or "no temperature measurement". For the subsequent time intervals after ROSC, data could not be collected from all the aforementioned 74 patients, because some of them died.

Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours.

Outcome measures

Outcome measures
Measure	Steroids Group n=34 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=40 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Core Body Temperature in Degrees Celcius. Temperature averaged over 0-6 hours after ROSC	36.5 Degrees Celcius Standard Deviation 1.1	35.6 Degrees Celcius Standard Deviation 5.7
Core Body Temperature in Degrees Celcius. Temperature averaged over 6-12 hours after ROSC	36.3 Degrees Celcius Standard Deviation 1.0	36.6 Degrees Celcius Standard Deviation 1.3
Core Body Temperature in Degrees Celcius. Temperature averaged over 12-18 hours after ROSC	36.0 Degrees Celcius Standard Deviation 1.0	36.5 Degrees Celcius Standard Deviation 1.1
Core Body Temperature in Degrees Celcius. Temperature averaged over 18-24 hours after ROSC	36.1 Degrees Celcius Standard Deviation 1.5	36.3 Degrees Celcius Standard Deviation 0.9
Core Body Temperature in Degrees Celcius. Temperature averaged over 24-30 hours after ROSC	36.1 Degrees Celcius Standard Deviation 1.1	36.2 Degrees Celcius Standard Deviation 1.0
Core Body Temperature in Degrees Celcius. Temperature averaged over 30-36 hours after ROSC	36.0 Degrees Celcius Standard Deviation 1.1	36.2 Degrees Celcius Standard Deviation 1.2
Core Body Temperature in Degrees Celcius. Temperature averaged over 36-42 hours after ROSC	36.1 Degrees Celcius Standard Deviation 1.0	36.2 Degrees Celcius Standard Deviation 1.2
Core Body Temperature in Degrees Celcius. Temperature averaged over 42-48 hours after ROSC	36.2 Degrees Celcius Standard Deviation 1.0	36.3 Degrees Celcius Standard Deviation 1.1

SECONDARY outcome

Timeframe: Time points of measurement: 4 and 72 hours postresuscitation.

Population: Data were collected from 29 patients (Control, n=15). Reasons for missing data were 1) patient death within less than 72 hours after ROSC; 2) severe postresuscitation shock precluding changes in vasopressor infusion rates to achieve the desired MAP levels; and 3) technical issues with the near infrared spectroscopy equipment.

Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC

Outcome measures

Outcome measures
Measure	Steroids Group n=15 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=14 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green. CBFI 4 HOURS POST-ROSC MEAN MAP=75.5 MMHG	4.0 nM/s Standard Deviation 2.5	3.3 nM/s Standard Deviation 2.1
Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green. CBFI 4 HOURS POST-ROSC MEAN MAP=96.0 MMHG	4.2 nM/s Standard Deviation 2.3	3.5 nM/s Standard Deviation 1.9
Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green. CBFI 72 HOURS POST-ROSC MEAN MAP=75.5 MMHG	4.3 nM/s Standard Deviation 3.5	3.4 nM/s Standard Deviation 2.2
Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green. CBFI 72 HOURS POST-ROSC MEAN MAP= 97.0 MMHG	4.9 nM/s Standard Deviation 3.8	3.8 nM/s Standard Deviation 2.4

SECONDARY outcome

Timeframe: Days 1 to 60 postrandomization.

Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore \<3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure.

Outcome measures

Outcome measures
Measure	Steroids Group n=46 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=54 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Organ Failure-free Days.	0 Number of Days without Organ Failure Interval 0.0 to 13.0	0 Number of Days without Organ Failure Interval 0.0 to 13.0

SECONDARY outcome

Timeframe: Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.

Population: At 4 hours after ROSC, reasons for missing data relative to total study population were 1) patient death within 4 hours after ROSC; and 2) non-adherence to protocol. Regarding the subsequent time points (i.e. 24, 48, and 72 hours), data was collected for \<72 patients (Control, n=41), as additional patients died or some samples were not collected.

Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture.

Outcome measures

SECONDARY outcome

Timeframe: Up to 180 days postrandomization.

Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death.

Outcome measures

Outcome measures
Measure	Steroids Group n=46 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=54 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Survival to Hospital Discharge With Favorable Functional Outcome.	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 180 days postrandomization.

Episodes of 1) Hyperglycemia (defined as Blood Glucose \>200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration \>150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection).

Outcome measures

Outcome measures
Measure	Steroids Group n=46 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=54 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Steroid-associated Complications. No. of Episodes of Hyperglycemia	0 Number of Episodes per Patient Interval 0.0 to 2.0	0 Number of Episodes per Patient Interval 0.0 to 2.0
Steroid-associated Complications. No. of Episodes of Hypernatremia	0 Number of Episodes per Patient Interval 0.0 to 0.0	0 Number of Episodes per Patient Interval 0.0 to 0.0
Steroid-associated Complications. No. of Episodes of Infections	0 Number of Episodes per Patient Interval 0.0 to 1.0	0 Number of Episodes per Patient Interval 0.0 to 1.0

Adverse Events

Steroids Group

Serious events: 45 serious events

Other events: 23 other events

Deaths: 45 deaths

Control Group

Serious events: 53 serious events

Other events: 33 other events

Deaths: 53 deaths

Serious adverse events

Serious adverse events
Measure	Steroids Group n=46 participants at risk Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock.	Control Group n=54 participants at risk Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase. Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock.
General disorders Second Cardiac Arrest	95.7% 44/46 • Number of events 44 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	90.7% 49/54 • Number of events 49 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders Cardiac arrest associated multiple organ failure	41.3% 19/46 • Number of events 19 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	37.0% 20/54 • Number of events 20 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders Acute Kidney Injury / Renal Failure	15.2% 7/46 • Number of events 7 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	18.5% 10/54 • Number of events 10 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Blood and lymphatic system disorders Severe Thrombocytopenia	13.0% 6/46 • Number of events 6 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	9.3% 5/54 • Number of events 5 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Infections and infestations Sepsis / Septic Shock	39.1% 18/46 • Number of events 18 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	31.5% 17/54 • Number of events 17 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Infections and infestations Hospital acquired pneumonia	23.9% 11/46 • Number of events 11 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	16.7% 9/54 • Number of events 9 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	8.7% 4/46 • Number of events 4 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	3.7% 2/54 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Infections and infestations Urinary tract infection	0.00% 0/46 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	3.7% 2/54 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders Postresuscitation heart failure	4.3% 2/46 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	0.00% 0/54 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders New life-threatening arrhythmia	4.3% 2/46 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	5.6% 3/54 • Number of events 3 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Gastrointestinal disorders Hepatic failure	0.00% 0/46 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	5.6% 3/54 • Number of events 3 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders Acute myocardial ischemia	2.2% 1/46 • Number of events 1 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	3.7% 2/54 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
Musculoskeletal and connective tissue disorders Paresis	6.5% 3/46 • Number of events 3 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	3.7% 2/54 • Number of events 2 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.
General disorders Other	10.9% 5/46 • Number of events 5 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	11.1% 6/54 • Number of events 6 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.

Other adverse events

Other adverse events
Measure	Steroids Group n=46 participants at risk Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock Of 369 cardiac arrest patients evaluated for eligibility, 100 patients were enrolled of whom 46 were randomized to receive 40 mg of methylprednisolone during resuscitation (first CPR cycle after enrollment), followed by stress dose hydrocortisone, starting at 4 hours postresuscitation in patients with postresuscitation shock.	Control Group n=54 participants at risk Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase. Of 369 cardiac arrest patients evaluated for eligibil ity, 100 patients were enrolled of whom 54 were randomized to receive placebo during resuscitation (first CPR cycle after enrollment), followed by placebo, starting at 4 hours postresuscitation in patients with postresuscitation shock.
General disorders HYPERGLYCEMIA	50.0% 23/46 • Number of events 313 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.	61.1% 33/54 • Number of events 395 • 180 days Specific Document reporting date of onset of serious adverse event (SAE), SEA location, SAE as unexpected (or not), brief description of affected participant and of SAE, effect of the SAE (e.g. death or life-threatening, etc.), required therapeutic intervention type, relationship of event to study intervention, whether study intervention was discontinued due to the SAE, list of SAE-relevant tests, type of report (initial, follow-up, or final), and list of concurrent medication.

Additional Information

Associate Professor in Intensive Care Medicine

National and Kapodistrian University of Athens

Phone: 00302132043307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Steroids Group n=31 Participants Intervention: Stress-dose Steroids. Patients will receive methylprednisolone 40 mg (on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation). After resuscitation, patients will be treated with stress-dose hydrocortisone 240 mg daily for 7 days maximum, followed by gradual taper over the next 2 days. Methylprednisolone; hydrocortisone: Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock	Control Group n=41 Participants Intervention: Saline placebo. Patients will receive saline placebo on the first, postenrollment cardiopulmonary resuscitation cycle. Otherwise, advanced life support will be conducted according to the 2015 guidelines for resuscitation. After resuscitation, patients will be treated with saline placebo for a maximum of 9 days (i.e. 7 days corresponding to the stress-dose hydrocortisone treatment of the experimental arm plus 2 days corresponding to the gradual taper of the stress-dose hydrocortisone treatment of the experimental arm). Saline Placebo: Saline placebo during resuscitation and during the postresuscitation phase.
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-6 at 4 hours after ROSC	2.19 Log(10) transformed values of pg/mL Standard Error 0.65	2.22 Log(10) transformed values of pg/mL Standard Error 0.57
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). TNFα at 4 hours after ROSC	1.97 Log(10) transformed values of pg/mL Standard Error 0.47	2.03 Log(10) transformed values of pg/mL Standard Error 0.47
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-1β at 4 hours after ROSC	2.07 Log(10) transformed values of pg/mL Standard Error 0.24	2.03 Log(10) transformed values of pg/mL Standard Error 0.21
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-8 at 4 hours after ROSC	2.39 Log(10) transformed values of pg/mL Standard Error 0.36	2.43 Log(10) transformed values of pg/mL Standard Error 0.50
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-10 at 4 hours after ROSC	1.76 Log(10) transformed values of pg/mL Standard Error 0.62	1.76 Log(10) transformed values of pg/mL Standard Error 0.76
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-6 at 24 hours after ROSC	2.06 Log(10) transformed values of pg/mL Standard Error 0.43	1.99 Log(10) transformed values of pg/mL Standard Error 0.55
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). TNFα at 24 hours after ROSC	2.02 Log(10) transformed values of pg/mL Standard Error 0.48	2.00 Log(10) transformed values of pg/mL Standard Error 0.51
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-1β at 24 hours after ROSC	2.06 Log(10) transformed values of pg/mL Standard Error 0.13	2.09 Log(10) transformed values of pg/mL Standard Error 0.91
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-8 at 24 hours after ROSC	2.27 Log(10) transformed values of pg/mL Standard Error 0.41	2.29 Log(10) transformed values of pg/mL Standard Error 0.45
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-10 at 24 hours after ROSC	1.69 Log(10) transformed values of pg/mL Standard Error 0.62	1.54 Log(10) transformed values of pg/mL Standard Error 0.65
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-6 at 48 hours after ROSC	1.87 Log(10) transformed values of pg/mL Standard Error 0.35	1.91 Log(10) transformed values of pg/mL Standard Error 0.51
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). TNFα at 48 hours after ROSC	1.99 Log(10) transformed values of pg/mL Standard Error 0.50	1.96 Log(10) transformed values of pg/mL Standard Error 0.50
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-1β at 48 hours after ROSC	2.09 Log(10) transformed values of pg/mL Standard Error 0.13	2.03 Log(10) transformed values of pg/mL Standard Error 0.16
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-8 at 48 hours after ROSC	2.15 Log(10) transformed values of pg/mL Standard Error 0.37	2.17 Log(10) transformed values of pg/mL Standard Error 0.41
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-10 at 48 hours after ROSC	1.56 Log(10) transformed values of pg/mL Standard Error 0.44	1.53 Log(10) transformed values of pg/mL Standard Error 0.44
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-6 at 72 hours after ROSC	1.93 Log(10) transformed values of pg/mL Standard Error 0.73	1.90 Log(10) transformed values of pg/mL Standard Error 0.47
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). TNFα at 72 hours after ROSC	2.00 Log(10) transformed values of pg/mL Standard Error 0.56	1.96 Log(10) transformed values of pg/mL Standard Error 0.51
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-1β at 72 hours after ROSC	2.05 Log(10) transformed values of pg/mL Standard Error 0.17	2.04 Log(10) transformed values of pg/mL Standard Error 0.12
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-8 at 72 hours after ROSC	2.15 Log(10) transformed values of pg/mL Standard Error 0.38	2.19 Log(10) transformed values of pg/mL Standard Error 0.32
Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL). IL-10 at 72 hours after ROSC	1.66 Log(10) transformed values of pg/mL Standard Error 0.61	1.45 Log(10) transformed values of pg/mL Standard Error 0.48