Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00676585
• Collaborator: American Heart Association (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Drug: Normal Saline; Drug: Hydrocortisone	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 2 Normal Saline	Drug: Normal Saline; Normal Saline
Experimental: 1 Hydrocortisone 100mg every 8 hours.	Drug: Hydrocortisone; Hydrocortisone 100mg

Outcome Measures

Primary Outcome Measures

1. Time to Shock Reversal [7 Days]

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

Secondary Outcome Measures

1. Mortality [Length of hospital stay, an average of 9 days with a maximum of 36 days]

2. Sub-group Analysis of Patients With Adrenal Insufficiency [At time of enrollment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Greater than 18 years old

• Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC

• Vasopressor dependent for a minimum of 1 hour post-arrest

Exclusion Criteria:

• Pregnant

• Indication for Corticosteroids outside of current research proposal

• DNR or comfort care measures

• Presence of septic shock

• Chronic Use (>1week) of oral Corticosteroids in the last year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• American Heart Association

Investigators

• Principal Investigator: Michael W Donnino, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Donnino, Michael Donnino, MD, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00676585
• Other Study ID Numbers: 2007P000227
• First Posted: May 13, 2008
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Michael Donnino, Michael Donnino, MD, Beth Israel Deaconess Medical Center: Cardiac Arrest, Shock, Steroids
• Additional relevant MeSH terms: Heart Arrest; Hydrocortisone

Study Results

Participant Flow

Arm/Group Title	Control	Intervention
Arm/Group Description	Normal Saline	Hydrocortisone
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	Normal Saline	Hydrocortisone	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (13)	66 (15)	69 (14)
Sex: Female, Male (Count of Participants)
Female	8 32%	9 36%	17 34%
Male	17 68%	16 64%	33 66%

Outcome Measures

1. Primary Outcome

Title	Time to Shock Reversal
Description	The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Normal Saline	Hydrocortisone
Measure Participants	25	25
Median (Inter-Quartile Range) [hours]	55	49

2. Secondary Outcome

Title	Mortality
Time Frame	Length of hospital stay, an average of 9 days with a maximum of 36 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Normal Saline	Hydrocortisone
Measure Participants	25	25
Count of Participants [Participants]	16 64%	18 72%

3. Secondary Outcome

Title	Sub-group Analysis of Patients With Adrenal Insufficiency
Description	Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL
Time Frame	At time of enrollment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Intervention
Arm/Group Description	Normal Saline	Hydrocortisone
Measure Participants	3	6
Shock Reversal in Adrenal Insufficient	1 4%	6 24%
Good Neurological Outcome in Adrenal Insufficient	0 0%	2 8%
Survival in Adrenal Insufficient	0 0%	3 12%

Adverse Events

Arm/Group Title	Control		Intervention
Arm/Group Description	Normal Saline		Hydrocortisone
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/25 (64%)		18/25 (72%)
General disorders
Death	16/25 (64%)		18/25 (72%)
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/25 (76%)		21/25 (84%)
Endocrine disorders
New insulin infusion	6/25 (24%)		7/25 (28%)
General disorders
Any Bleeding	2/25 (8%)		5/25 (20%)
Infections and infestations
New or Changed Antibiotics	11/25 (44%)		9/25 (36%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.