# 1/2 ICECAP: Influence of Cooling duration on Efficacy in Cardiac Arrest Patients

> **NIH NIH UH3** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $7,358,135

## Abstract

7. Project Summary/Abstract .
Cardiac arrest is a common and devastating emergency of the heart and the brain. More than 380,000
patients suffer out of hospital cardiac arrest (OHCA) each year in the US. Improvements in cardiac
resuscitation (the early links in the “chain of survival” for patients with OHCA) are tempered by our limited
ability to resuscitate and protect the brain from global cerebral ischemia. Neurological death and disability are
common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from
shockable rhythms may markedly increase the rate of good neurological outcome, but poor outcomes still
occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless
electrical activity has not been evaluated in a randomized study. Even in patients with shockable rhythms, prior
trials showing efficacy have been questioned. Therapeutic cooling is already a guideline-recommended and
commonly used treatment in comatose survivors of cardiac arrest, but because of limited data, the optimal
duration and patient selection criteria remain unknown and cooling devices are not FDA approved for this
indication. Preclinical data and mechanistic studies strongly suggest that durations of hypothermia longer than
those typically used may minimize brain injury. This study will determine if identifying an optimal duration of
therapeutic hypothermia can improve outcomes, and if development of a duration response curve can
substantiate efficacy in a wider patient population of cardiac arrest survivors. We hypothesize that longer
durations of cooling may improve either the proportion of patients that attain a good neurological recovery or
may result in better recovery among the proportion already categorized as having good outcome. The
overarching goal of this project is to identify clinical strategies that will increase the number of patients with
good neurological recovery from cardiac arrest. The results of this trial will be immediately significant,
impacting both clinical practice and regulatory evaluation. The trial uses innovative adaptive dose finding
methods that allow exploration of a wide range of potential durations and efficiently allocate subjects where
they will be most informative. The study methods also include innovative approaches to traditional outcome
assessment and innovative outcome assessment tools, including the NIH Toolbox. The study will be
conducted in the NIH SIREN Emergency Clinical Trials infrastructure. SIREN leverages existing resources to
achieve economies of scale, maintain talented rapidly responding teams to screen and enroll subjects in the
emergency department setting, and to continue clinical investigations through the ICU stay and beyond with
proven performance.

## Key facts

- **NIH application ID:** 10265491
- **Project number:** 5UH3HL145269-03
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Romergryko Geocadin
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $7,358,135
- **Award type:** 5
- **Project period:** 2019-09-19 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10265491

## Citation

> US National Institutes of Health, RePORTER application 10265491, 1/2 ICECAP: Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (5UH3HL145269-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10265491. Licensed CC0.

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