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Hypothermia + Neuromuscular Blockers for Respiratory Distress Syndrome (CHILL Trial)
Phase 2
Waitlist Available
Led By Jeffrey D Hasday, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to a participating ICU
P/F ratio ≤200 with PEEP ≥8 cm H2O and FiO2≥0.6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at randomization and as close to 0800 as possible on study days 1 2, 3, 4, and 7 or until extubation whichever occurs first
Awards & highlights
CHILL Trial Summary
This trial is testing whether a combination of therapeutic hypothermia and neuromuscular blocking agents is beneficial for patients with ARDS.
Who is the study for?
This trial is for patients with ARDS, a severe lung condition often seen after illnesses like COVID-19. Participants must be on mechanical ventilation ≤7 days, have specific blood oxygen levels, and show certain X-ray findings. Exclusions include those with severe chronic diseases, recent heart attacks or cardiac arrest, extensive burns, pregnancy, or if they're unlikely to survive the short term.Check my eligibility
What is being tested?
The study tests whether cooling the body (therapeutic hypothermia) combined with muscle relaxants improves outcomes in ARDS patients compared to standard temperature management. It's a randomized trial involving 340 participants over approximately 3.5 years at multiple centers.See study design
What are the potential side effects?
Potential side effects may include shivering (often controlled by muscle relaxants), risks associated with lower body temperatures such as infections or abnormal heart rhythms, and possible complications from prolonged use of neuromuscular blocking agents.
CHILL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently admitted to an ICU that is part of the study.
Select...
My breathing support settings are high due to severe lung issues.
CHILL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at randomization and as close to 0800 as possible on study days 1 2, 3, 4, and 7 or until extubation whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at randomization and as close to 0800 as possible on study days 1 2, 3, 4, and 7 or until extubation whichever occurs first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
28-day ventilator-free days (VFDs)
Secondary outcome measures
28-day ICU-free days
Airway driving pressure
Complete blood count with differential count and platelet count
+12 moreCHILL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypothermia + Neuromuscular blockadeExperimental Treatment2 Interventions
Deep sedation and Neuromuscular blockade (NMB) and surface temperature management to maintain core temperature between 34 and 35°C for 48h, then rewarm to 36°C at 0.33°C per h and NMB discontinued when core temp reaches 35.5°C.
Group II: Usual Temperature ManagementActive Control1 Intervention
Acetaminophen and surface temperature management to maintain core temperature between 37°C and 38°C. Rewarming to 37°C for hypothermia ≤36°C with continuous renal replacement therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypothermia
2009
Completed Phase 2
~1630
Neuromuscular Blocking Agents
2019
N/A
~290
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,306 Total Patients Enrolled
1 Trials studying Respiratory Distress Syndrome
US Department of Veterans Affairs Cooperative Studies ProgramNETWORK
1 Previous Clinical Trials
300 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
226,854 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
1,093 Patients Enrolled for Respiratory Distress Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using oxygen at home.I have needed strong medicine to maintain my blood pressure for more than 6 hours.Unlikely to need a breathing tube for at least 48 hoursI have a severe lung condition.I have severe heart disease.I have had a heart attack or unstable angina in the last 30 days.I have severe liver disease.My current doctor is not willing to be involved in the trial.I have burns covering more than 20% of my body.I have an active blood cancer.I have not had a cardiac arrest in the last 30 days.I am currently admitted to an ICU that is part of the study.My breathing support settings are high due to severe lung issues.I have not needed more than 3 units of blood or any surgery to stop bleeding today.You are very sick and not expected to live for the next 3 days.You have a "do not resuscitate" order in place at the time of being chosen for the study.Your body temperature is less than 35.5°C without receiving CRRT on the day of enrollment.Your symptoms must match both Condition 3 and Condition 4 within 72 hours of joining the study. They can't be fully explained by a certain type of lung swelling, and they must have started within 7 days of being around something that could cause a risk of lung injury, like a serious infection.You are using BIPAP for a condition other than obstructive sleep apnea.You didn't take the medication within 48 hours.I have had a lung transplant.You have been on a ventilator for more than 7 days.I have been on a ventilator for 7 days or less with a tube in my windpipe.You were diagnosed with ARDS more than 72 hours ago.Your existing health condition makes it unlikely for you to survive for 28 days.You have a consistently high body mass index (BMI) of over 50 kg/m2.I cannot use cooling devices due to a skin condition.Your lung X-rays show signs of infection or fluid buildup not related to heart or lung conditions.Your platelet count is less than 10,000 per cubic millimeter on the day you are scheduled to be chosen for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Hypothermia + Neuromuscular blockade
- Group 2: Usual Temperature Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different medical facilities is this clinical trial taking place?
"The primary research centres for this study are Cleveland Clinc in Ohio, Cooper Health System in New jersey, and University of Chicago in Illinois; however, the study is also being conducted at 16 other locations."
Answered by AI
Does the FDA condone using both hypothermia and neuromuscular blockade together?
"While there is some evidence that this combination of treatments is safe, it remains unproven whether or not it is effective. Therefore, our team at Power have given it a score of 2."
Answered by AI
How can I become a participant in this clinical trial?
"This medical trial is looking for 340 participants between the ages of 18 and 75 who have hypothermia. In addition to this, patients must meet the following criteria: Criteria 3 AND 4 must be met within 72h of enrollment and randomization, not be fully explained by hydrostatic pulmonary edema, and must have occurred within 7 days of exposure to an ARDS-risk factor (including continuous exposure to persistent processes (e.g. sepsis, pneumonia, COVID-19). Patients must also have an endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;"
Answered by AI
Are the age requirements for participants in this study flexible?
"The age limit for this clinical trial is 75 years old, with a minimum age of 18."
Answered by AI
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