A Phase 1/2 interventional study of Normal Saline and Hydrocortisone in Cardiac Arrest, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Beth Israel Deaconess Medical Center · Phase 1/2, Interventional, and Treatment
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Normal Saline
Drug: Normal Saline
Hydrocortisone 100mg every 8 hours.
Drug: Hydrocortisone
Normal Saline
Hydrocortisone 100mg
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
Mortality
Time frame: Length of hospital stay, an average of 9 days with a maximum of 36 days
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
| Milestone | Control | Intervention |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
| hours | Control | Intervention |
|---|---|---|
| Time to Shock Reversal | 55 (30 to 59) | 49 (25 to 71) |
| Participants | Control | Intervention |
|---|---|---|
| Mortality | 16 | 18 |
Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level \< 15 ug/dL
| Participants | Control | Intervention |
|---|---|---|
| Shock Reversal in Adrenal Insufficient | 1 | 6 |
| Good Neurological Outcome in Adrenal Insufficient | 0 | 2 |
| Survival in Adrenal Insufficient | 0 | 3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 16/25 (64%) | 19/25 (76%) |
| Intervention | — | 18/25 (72%) | 21/25 (84%) |
| Event | Control | Intervention |
|---|---|---|
| DeathGeneral disorders | 16/25 | 18/25 |
| Event | Control | Intervention |
|---|---|---|
| New or Changed AntibioticsInfections and infestations | 11/25 | 9/25 |
| New insulin infusionEndocrine disorders | 6/25 | 7/25 |
| Any BleedingGeneral disorders | 2/25 | 5/25 |
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 71 ± 13 | 66 ± 15 | 69 ± 14 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 17 | 16 | 33 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beth Israel Deaconess Medical Center