Cardiac Arrest
Conditions
Keywords
Cardiac Arrest, Shock, Steroids
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.
Interventions
DRUGNormal Saline
Normal Saline
DRUGHydrocortisone
Hydrocortisone 100mg
Sponsors
American Heart Association
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Length of hospital stay, an average of 9 days with a maximum of 36 days | — |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Normal Saline | 25 |
| Intervention Hydrocortisone | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 15 | 69 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 25 | 21 / 25 |
| serious Total, serious adverse events | 16 / 25 | 18 / 25 |
Outcome results
Primary
Time to Shock Reversal
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
Time frame: 7 Days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time to Shock Reversal | 55 hours |
| Intervention | Time to Shock Reversal | 49 hours |
Secondary
Mortality
Time frame: Length of hospital stay, an average of 9 days with a maximum of 36 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Mortality | 16 Participants |
| Intervention | Mortality | 18 Participants |
Secondary
Sub-group Analysis of Patients With Adrenal Insufficiency
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Sub-group Analysis of Patients With Adrenal Insufficiency | Shock Reversal in Adrenal Insufficient | 1 Participants |
| Control | Sub-group Analysis of Patients With Adrenal Insufficiency | Good Neurological Outcome in Adrenal Insufficient | 0 Participants |
| Control | Sub-group Analysis of Patients With Adrenal Insufficiency | Survival in Adrenal Insufficient | 0 Participants |
| Intervention | Sub-group Analysis of Patients With Adrenal Insufficiency | Good Neurological Outcome in Adrenal Insufficient | 2 Participants |
| Intervention | Sub-group Analysis of Patients With Adrenal Insufficiency | Shock Reversal in Adrenal Insufficient | 6 Participants |
| Intervention | Sub-group Analysis of Patients With Adrenal Insufficiency | Survival in Adrenal Insufficient | 3 Participants |