Trial of Therapeutic Hypothermia in Patients With ARDS

PHASE2RecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

June 29, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Respiratory Distress Syndrome, Adult
Interventions
DEVICE

Hypothermia

Subjects will be cooled using either cooling blankets or gel-pad systems to maintain core temperature 34-35°C.

DRUG

Neuromuscular Blocking Agents

Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium, atracurium, or vecuronium titrated to 2 twitches on train of four monitoring and further titrated to ablate visible shivering.

DEVICE

Standard of care

Subjects who are hypothermic (≤36°C) during CRRT will receive surface warming to restore core temperature to 37°C. Patients with core temperature \>38°C will receive 650 mg acetaminophen and, if temperature remains \>38°C, surface cooling will be initiated to return core temperature to 37-38°C.

Trial Locations (15)

19104

RECRUITING

University of Pennsylavia, Philadelphia

19107

RECRUITING

Thomas Jefferson University, Philadelphia

19140

RECRUITING

Temple University, Philadelphia

21201

RECRUITING

University of Maryland Medical Center, Baltimore

21205

RECRUITING

Johns Hopkins Hospital, Baltimore

30322

RECRUITING

Emory University, Atlanta

44195

RECRUITING

Cleveland Clinc, Cleveland

53792

RECRUITING

University of Wisconsin, Madison

60612

RECRUITING

Rush University Medical Center, Chicago

60660

TERMINATED

Loyola University Chicago, Chicago

78234

RECRUITING

Brooke Army Medical Center, Fort Sam Houston

84132

RECRUITING

Intermountain Healthcare (Utah), Salt Lake City

97239

RECRUITING

Oregon Health & Science University, Portland

06520

RECRUITING

Yale University, New Haven

08103

RECRUITING

Cooper Health System, Camden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

US Department of Veterans Affairs Cooperative Studies Program

NETWORK

collaborator

KAI Research

OTHER

collaborator

United States Department of Defense

FED

lead

University of Maryland, Baltimore

OTHER

NCT04545424 - Trial of Therapeutic Hypothermia in Patients With ARDS | Biotech Hunter | Biotech Hunter