Cardiac ArrestPhase 1/2NCT00676585
Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
A Phase 1/2 study testing Normal Saline and Hydrocortisone in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Normal Saline and Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
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.
- Conditions
- Cardiac Arrest
- Being tested
- Normal Saline, Hydrocortisone
- Keywords
- Cardiac Arrest, Shock, Steroids
- Medical subject headings
- Heart Arrest, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Normal Saline
HydrocortisoneDrug
Hydrocortisone 100mg
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Normal Saline Receives: Drug: Normal Saline |
| 1 | Experimental | Hydrocortisone 100mg every 8 hours. Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Shock Reversal
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
Measured: 7 Days
Secondary outcomes (2)
Mortality
Measured: 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
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael W Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676585
- Sponsor's protocol ID
- 2007P000227
- Status last verified
- May 2017
- First submitted
- 9 May 2008
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.
PubMed 27038920
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00676585
- Acronym / sponsor ID
- 2007P000227
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Shock, Steroids
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Oct 2007
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Normal SalineNormal Saline |
| 1 | Experimental | Drug: HydrocortisoneHydrocortisone 100mg every 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineNormal Saline | Drug | 2 |
| HydrocortisoneHydrocortisone 100mg | Drug | 1 |
Primary outcome
Time to Shock Reversal
Time frame: 7 Days
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
2 secondary outcomes
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
Time frame: At time of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27038920Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Normal Saline and Hydrocortisone in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Shock Reversal (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.