Trial Outcomes & Findings for Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (NCT NCT03640949)

Results Overview

Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

501 participants

Primary outcome timeframe

During the cardiac arrest, an average of 20 minutes

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Vasopressin and Methylprednisolone The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once	Placebo The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo
Overall Study STARTED	237	264
Overall Study COMPLETED	237	264
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vasopressin and Methylprednisolone n=237 Participants The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once	Placebo n=264 Participants The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo	Total n=501 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 13 • n=237 Participants	70 years STANDARD_DEVIATION 12 • n=264 Participants	71 years STANDARD_DEVIATION 13 • n=501 Participants
Sex: Female, Male Female	89 Participants n=237 Participants	90 Participants n=264 Participants	179 Participants n=501 Participants
Sex: Female, Male Male	148 Participants n=237 Participants	174 Participants n=264 Participants	322 Participants n=501 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: During the cardiac arrest, an average of 20 minutes

Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes

Outcome measures

Outcome measures
Measure	Vasopressin and Methylprednisolone n=237 Participants The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once	Placebo n=264 Participants The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo
Number of Participants With Return of Spontaneous Circulation	100 participants	86 participants

SECONDARY outcome

Timeframe: At 30 days

Outcome measures

Outcome measures
Measure	Vasopressin and Methylprednisolone n=237 Participants The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once	Placebo n=264 Participants The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo
Number of Participants That Survived 30 Days	23 Participants	31 Participants

SECONDARY outcome

Timeframe: At 30 days

A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.

Outcome measures

Outcome measures
Measure	Vasopressin and Methylprednisolone n=237 Participants The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin, Arginine: 20 IE of vasopressin per dose for a maximum of four doses (80 IU) Methylprednisolone: 40 mg methylprednisolone once	Placebo n=264 Participants The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. NaCl: Placebo
Number of Participants With a Favorable Neurological Outcome at 30 Days	18 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Vasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Invasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24, 48 and 72 hours

The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At hospital discharge, up to 1 year

Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 90 days, 180 days, and 1 year

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 90 days, 180 days, and 1 year

A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 30 days, 90 days, 180 days, and 1 year

The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 30 days, 90 days, 180 days, and 1 year

The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 30 days, 90 days, 180 days, and 1 year

The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1).

Outcome measures

Outcome data not reported

Adverse Events

Vasopressin and Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 214 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 233 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lars W. Andersen

Aarhus University

Phone: +4551781511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place