Trial of Therapeutic Hypothermia in Patients With ARDS (NCT04545424) | Clinical Trial Compass
RecruitingPhase 2
Trial of Therapeutic Hypothermia in Patients With ARDS
United States340 participantsStarted 2021-06-29
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;
✓. admitted to a participating ICU
✓. radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema
✓. P/F ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values based on Table 3 from Brown et al as long as following conditions are met:
✓. SpO2 values are 80-96%
✓. SpO2 is measured ≥10 min after any change in FIO2
✓. PEEP is ≥ 8 cm H2O
✓. the pulse oximeter waveform tracing is adequate
Exclusion criteria
✕. Missed moderate-severe ARDS window (\>72hrs) - Window starts when patient is intubated with a qualifying P/F ratio of ≤ 200 with PEEP ≥ 8 cm H2O or on high flow nasal oxygen with well-fitting nasal cannula with flow ≥ 40 LPM and FiO2 ≥ 0.65 or on non-invasive pressure ventilation with PEEP ≥ 8 cm H2O and FiO2 ≥ 0.6.
What they're measuring
1
28-day ventilator-free days (VFDs)
Timeframe: Calculated at study day 28 or death (whichever occurs first)
✕. Refractory hypotension (continuous infusion of \>0.3 mcg/kg/min of norepinephrine or equivalent dose of other vasopressors within 2 hours prior to randomization)
✕. Core temperature \<35°C for ≥6 hours while not receiving CRRT on day of randomization
✕. Significant, active bleeding (\>3u blood products and/or surgical/IR intervention) on day of randomization
✕. Platelets \<10K/mm3 (uncorrected) on day of randomization
✕. Active hematologic malignancy and not expected to survive 6 months