Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS
Withdrawn before enrolling · Phase 2
Conditions studied: Respiratory Distress Syndrome, Adult, Sars-CoV2
In brief
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 investigators sought to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. The investigators are scheduled to begin enrolling in a Department of Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients with ARDS with time on ventilator as the primary outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study to examine the safety and feasibility of including patients with COVID-19-associated ARDS in our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and maintaining the target temperature. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2, 3, 4, and 7.
Key facts
- Study ID
- NCT03376854
- Run by
- University of Maryland, Baltimore
- People needed
- 0
- Starts
- 2018-05-01
- Expected to finish
- 2021-04-27
- Last updated by the study team
- 2021-04-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Missed ARDS window (>48hrs)
- Missed mechanical ventilation window (>7 days)
- Refractory hypotension (> 0.2 mcg/kg/min of norepinephrine or equivalent dose for minimum of 6 h)
- Core temperature <35.5°C while not receiving CRRT
- Patient is unable to give consent and no legally authorized representative is available;
- Significant, active bleeding (>3u blood products and/or surgical/IR intervention)
- Platelets <10K/mm3 (uncorrected)
- Active hematologic malignancy
- Skin process precludes cooling device
- Moribund, not likely to survive 72h
- Pre-morbid condition makes it unlikely that patient will survive 28 days
- Do Not Resuscitate status
- Not likely to remain intubated for ≥48h
- Physician unwilling to participate
- Severe underlying lung disease
- On home O2
- On BIPAP (except for OSA)
- Prior lung transplantation
- BMI >45 kg/m2
- Known NYHA class IV heart disease
- Acute Coronary Syndrome past 30 days (MI, unstable angina)
- Cardiac arrest within 30 days of enrollment
- burns over >20% of the body surface
- severe chronic liver disease (Child-Pugh of 12-15)
- Previously randomized in CHILL study
Where it is running
- University of Maryland Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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