Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

Not Applicable

Recruiting

• Conditions: Cardiac Arrest, Out-Of-Hospital; Hypothermia, Induced; Hypoxia-Ischemia, Brain

• Registration Number: NCT04217551
• Lead Sponsor: University of Michigan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Inclusion Criteria:<br><br> - Coma after resuscitation from out of hospital cardiac arrest<br><br> - Cooled to <34 deg C with 240 minutes of cardiac arrest<br><br> - Definitive temperature control applied<br><br> - Age = 18 years<br><br> - Informed consent from legal authorized representative (LAR) including intent to<br> maintain life support for 96 hours<br><br> - Enrollment within 6 hours of initiation of cooling<br><br>Exclusion Criteria:<br><br> - Hemodynamic instability<br><br> - Pre-existing neurological disability or condition that confounds outcome<br> determination<br><br> - Pre-existing terminal illness, unlikely to survive to outcome determination<br><br> - Planned early withdrawal of life support<br><br> - Presumed sepsis as etiology of arrest<br><br> - Prisoner

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weighted Modified Rankin Scale (mRS)

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality;NIH Toolbox Crystallized Cognition Composite Score;NIH Toolbox Fluid Cognition Composite Score;Pneumonia;Other infection;Malignant cardiac arrhythmia;Seizures;Neurological worsening;Electrolyte abnormalities;Coagulopathies