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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06207201
Other study ID # 2022-14602
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2023
Est. completion date August 2024

Study information

Verified date January 2024
Source Montefiore Medical Center
Contact Luke Andrea
Phone (718) 920-5731
Email landrea@montefiore.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Discover In-Hospital Cardiac Arrest (IHCA) study is a multicenter, prospective observational study aimed at better understanding variations in practice for the post-in-hospital cardiac arrest patient.


Description:

There is considerable debate among experts concerning many components of intra- and post-arrest care. This study aims to increase the evidence base of these components, particularly temperature control, and prognostication in post-in-hospital cardiac arrest patients. In addition to providing insights regarding immediate and long-term post-arrest care, data collected will also be useful in studying variations in cardiopulmonary resuscitation practices. This project is endorsed by the Society of Critical Care Medicine's (SCCM) Discovery, the Critical Care Research Network.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (=18 years old) patients - Patients with a cardiac arrest (a lack of palpable pulse or perfusing cardiac activity) while admitted to the hospital - Patients admitted to a ward (telemetry or non-telemetry) or an intensive care unit, or are admitted but still in the emergency department waiting for a hospital bed - Patients who achieved return of spontaneous circulation (ROSC defined as >20 minutes of sustained spontaneous circulation) OR initiated on extracorporeal membrane oxygenation (eCPR) with chest compressions ongoing Exclusion Criteria: - Cardiac arrest in non-inpatients (e.g. outpatients, visitors) - Patients whose cardiopulmonary resuscitation (CPR) starts outside of the hospital - Non-index arrests (arrests that are not the patient's first arrest during the hospital admission; this also excludes patients who were initially admitted for an out-of-hospital cardiac arrest) - Patients suffering IHCA in the operating room (OR) or post anesthesia care unit (PACU) - Patients with cardiac arrest after arriving to an emergency department (ED) but prior to being evaluated and admitted to the hospital - Cardiac arrests lasting <2 minutes (i.e. chest compressions performed <2 minutes) - Cardiac arrests where the patient is transitioned to comfort focused care within 6 hours of return of spontaneous circulation (ROSC)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Society of Critical Care Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fever Incidence The incidence of fever from ROSC until 96 hours after ROSC among patients who remain comatose Up to 96-hours post cardiac arrest
Primary Multimodal Prognostication The use of at least two approaches for prognostication prior to withdrawal of care from ROSC until hospital discharge Up to 60 days post cardiac arrest
Primary Early Withdrawal of Care The withdrawal of care from ROSC until 72-hour after ROSC Up to 72-hours post cardiac arrest
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