Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04545424 · ClinicalTrials.gov registry record · Phase 2
Trial of Therapeutic Hypothermia in Patients With ARDS
A Phase 2 study of Respiratory Distress Syndrome, Adult, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
- 19
- Study locations
NCT04545424 is a Phase 2 study of Respiratory Distress Syndrome, Adult that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 340 participants, above the 278-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (22% higher). The trial reports 19 study locations across 14 states.
The verdict
NCT04545424, a Phase 2 study of Respiratory Distress Syndrome, Adult, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
- 19
- Study locations
Study Summary
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over \~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7.
Conditions Studied
Interventions
- DEVICE Hypothermia
- DRUG Neuromuscular Blocking Agents
- DEVICE Standard of care
Study Locations (19)
Pennsylvania
- University of Pennsylavia - Philadelphia
- Thomas Jefferson University - Philadelphia
- Temple University - Philadelphia
Illinois
- Rush University Medical Center - Chicago
- Loyola University Chicago - Chicago
Maryland
- University of Maryland Medical Center - Baltimore
- Johns Hopkins Hospital - Baltimore
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinc - Cleveland
California
- Cedars-Sinai Medical Center - Los Angeles
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545424
The ClinicalTrials.gov registry entry for NCT04545424 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 278-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (22% higher). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Distress Syndrome, Adult appearing as the primary indexed condition, and to 3 interventions - of which Hypothermia is the first listed.
NCT04545424 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Pennsylvania, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT04545424 about?
NCT04545424 is a clinical study titled "Trial of Therapeutic Hypothermia in Patients With ARDS". Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, ...
What is the current status of trial NCT04545424?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2021-06-29. Estimated completion is 2026-10-31.
What conditions does trial NCT04545424 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Adult.
What interventions are being tested in trial NCT04545424?
The interventions under investigation include: Hypothermia (DEVICE), Neuromuscular Blocking Agents (DRUG), Standard of care (DEVICE).
Who is sponsoring clinical trial NCT04545424?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545424 being conducted?
This trial has 19 study locations across California, Connecticut, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Distress Syndrome, Adult
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Long Term Follow up of Children Enrolled in the REDvent Study
ACTIVE NOT RECRUITING
-
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
COMPLETED · Phase 1
-
Identifying PARDS Endotypes
COMPLETED
-
Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)
COMPLETED · Phase 3
-
Carbon Monoxide to Prevent Lung Inflammation
COMPLETED · Phase 1
-
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.