Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients
ICECAP
2 other identifiers
interventional
1,158
1 country
76
Brief Summary
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Longer than P75 for not_applicable
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2025
CompletedJune 25, 2025
June 1, 2025
5.3 years
December 30, 2019
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weighted Modified Rankin Scale (mRS)
The mRS is a 7 level ordinal scale of disability that ranges from 0 (no symptoms at all) to 6 (death). ICECAP uses weighting of mRS states to capture changes in functional status.
90 days after return of spontaneous circulation
Secondary Outcomes (10)
All Cause Mortality
90 days after return of spontaneous circulation
NIH Toolbox Crystallized Cognition Composite Score
90 days after return of spontaneous circulation
NIH Toolbox Fluid Cognition Composite Score
90 days after return of spontaneous circulation
Pneumonia
90 days after return of spontaneous circulation
Other infection
90 days after return of spontaneous circulation
- +5 more secondary outcomes
Study Arms (20)
6 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
12 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
18 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
24 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
30 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
36 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
42 Hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
48 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
60 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
72 hours - shockable
EXPERIMENTALParticipants with shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
6 hours - non shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
12 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
18 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
24 hour - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
30 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
36 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
42 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
48 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
60 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
72 hours - non-shockable
EXPERIMENTALParticipants with non-shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Interventions
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Eligibility Criteria
You may qualify if:
- Coma after resuscitation from out of hospital cardiac arrest
- Cooled to \<34 deg C with 240 minutes of cardiac arrest
- Definitive temperature control applied
- Age ≥ 18 years
- Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
- Enrollment within 6 hours of initiation of cooling
You may not qualify if:
- Hemodynamic instability
- Pre-existing neurological disability or condition that confounds outcome determination
- Pre-existing terminal illness, unlikely to survive to outcome determination
- Planned early withdrawal of life support
- Presumed sepsis as etiology of arrest
- Prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Johns Hopkins Universitycollaborator
- Medical University of South Carolinacollaborator
- National Institutes of Health (NIH)collaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (76)
University of Alabama Hospital
Birmingham, Alabama, 35233, United States
Banner University Medical Center
Tucson, Arizona, 85719, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, 90095, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
UF Health Shands Hospital
Gainesville, Florida, 32608, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois-Chicago Hosptial
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
DMC Sinai Grace Hospital
Detroit, Michigan, 48235, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
South Shore University Hospital
Bay Shore, New York, 11706, United States
NYU Langone Health - Tisch Hospital
New York, New York, 10016, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
NYP Columbia University Medical Center
New York, New York, 10032, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
ECU Health Medical Center
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45220, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
OSU East Hospital
Columbus, Ohio, 43203, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Adventist Health
Portland, Oregon, 97216, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Parkland Hospital
Dallas, Texas, 75235, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (3)
Meurer WJ, Schmitzberger FF, Yeatts S, Ramakrishnan V, Abella B, Aufderheide T, Barsan W, Benoit J, Berry S, Black J, Bozeman N, Broglio K, Brown J, Brown K, Carlozzi N, Caveney A, Cho SM, Chung-Esaki H, Clevenger R, Conwit R, Cooper R, Crudo V, Daya M, Harney D, Hsu C, Johnson NJ, Khan I, Khosla S, Kline P, Kratz A, Kudenchuk P, Lewis RJ, Madiyal C, Meyer S, Mosier J, Mouammar M, Neth M, O'Neil B, Paxton J, Perez S, Perman S, Sozener C, Speers M, Spiteri A, Stevenson V, Sunthankar K, Tonna J, Youngquist S, Geocadin R, Silbergleit R; ICECAP trial investigators. Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest. Trials. 2024 Jul 23;25(1):502. doi: 10.1186/s13063-024-08280-w.
PMID: 39044295BACKGROUNDMeurer W, Schmitzberger F, Yeatts S, Ramakrishnan V, Abella B, Aufderheide T, Barsan W, Benoit J, Berry S, Black J, Bozeman N, Broglio K, Brown J, Brown K, Carlozzi N, Caveney A, Cho SM, Chung-Esaki H, Clevenger R, Conwit R, Cooper R, Crudo V, Daya M, Harney D, Hsu C, Johnson NJ, Khan I, Khosla S, Kline P, Kratz A, Kudenchuk P, Lewis RJ, Madiyal C, Meyer S, Mosier J, Mouammar M, Neth M, O'Neil B, Paxton J, Perez S, Perman S, Sozener C, Speers M, Spiteri A, Stevenson V, Sunthankar K, Tonna J, Youngquist S, Geocadin R, Silbergleit R. Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest. Res Sq [Preprint]. 2024 Jun 21:rs.3.rs-4033108. doi: 10.21203/rs.3.rs-4033108/v1.
PMID: 38947064DERIVEDChen CT, Lin JW, Wu CH, Kuo RN, Shih CH, Hou PC, Yen DH, How CK. A Simple Risk Score for Predicting Neurologic Outcome in Out-of-Hospital Cardiac Arrest Patients After Targeted Temperature Management. Crit Care Med. 2022 Mar 1;50(3):428-439. doi: 10.1097/CCM.0000000000005266.
PMID: 34495880DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Meurer
University of Michigan
- PRINCIPAL INVESTIGATOR
Robert Silbergleit
University of Michigan
- PRINCIPAL INVESTIGATOR
Romer Geocadin
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessors will be blinded to the treatment assignment of the participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Emergency Medicine and Neurology
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 3, 2020
Study Start
May 18, 2020
Primary Completion
September 5, 2025
Study Completion
September 5, 2025
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 1 year after publication on main outcome results paper
- Access Criteria
- Data use agreement with the appropriate NHLBI repository
The data will be stored in the NHLBI data repository after trial completion.