Trial Outcomes & Findings for Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest (NCT NCT00676585)

NCT ID: NCT00676585

Last Updated: 2017-05-17

Results Overview

The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 7 Days
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Control Normal Saline	Intervention Hydrocortisone
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Baseline characteristics by cohort

Measure	Control n=25 Participants Normal Saline	Intervention n=25 Participants Hydrocortisone	Total n=50 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 13 • n=5 Participants	66 years STANDARD_DEVIATION 15 • n=7 Participants	69 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 Days

The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.

Outcome measures

Measure	Control n=25 Participants Normal Saline	Intervention n=25 Participants Hydrocortisone
Time to Shock Reversal	55 hours Interval 30.0 to 59.0	49 hours Interval 25.0 to 71.0

SECONDARY outcome

Timeframe: Length of hospital stay, an average of 9 days with a maximum of 36 days

Outcome measures

Measure	Control n=25 Participants Normal Saline	Intervention n=25 Participants Hydrocortisone
Mortality	16 Participants	18 Participants

SECONDARY outcome

Timeframe: At time of enrollment

Population: There were 9 patients identified with baseline absolute cortisol deficiency (3 in the control arm and 6 in the intervention arm). This sub population of study participants were analyzed for shock reversal, good neurological outcomes, and survival as shown in each row of the table below.

Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL

Outcome measures

Measure	Control n=3 Participants Normal Saline	Intervention n=6 Participants Hydrocortisone
Sub-group Analysis of Patients With Adrenal Insufficiency Shock Reversal in Adrenal Insufficient	1 Participants	6 Participants
Sub-group Analysis of Patients With Adrenal Insufficiency Good Neurological Outcome in Adrenal Insufficient	0 Participants	2 Participants
Sub-group Analysis of Patients With Adrenal Insufficiency Survival in Adrenal Insufficient	0 Participants	3 Participants

Adverse Events

Control

Serious events: 16 serious events

Other events: 19 other events

Deaths: 0 deaths

Intervention

Serious events: 18 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=25 participants at risk Normal Saline	Intervention n=25 participants at risk Hydrocortisone
General disorders Death	64.0% 16/25	72.0% 18/25

Other adverse events

Measure	Control n=25 participants at risk Normal Saline	Intervention n=25 participants at risk Hydrocortisone
Infections and infestations New or Changed Antibiotics	44.0% 11/25	36.0% 9/25
Endocrine disorders New insulin infusion	24.0% 6/25	28.0% 7/25
General disorders Any Bleeding	8.0% 2/25	20.0% 5/25

Additional Information

Dr. Michael Donnino

Beth Israel Deaconess Medical Center

Email: mdonnino@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place