Phase IIB Randomized Control Trial of Therapeutic Hypothermia (TH) plus Neuromuscular Blockade (NMB) in Patients with ARDS.

For screening, contact via Halo: HFH DEM Research

Inclusion Criteria:

• Mechanically ventilated for ≤ 7 days (trach ok also)
• Severe ARDS by Berlin criteria:
  • P/F ratio <200 with PEEP ≥8 cm H2O
  • Bilateral infiltrates not completely explained by hydrostatic pulmonary edema or atelectasis
  • Occurring within 7 days of exposure to a predisposing condition (ongoing exposure, not just initiation of the predisposing condition).
• Randomization must occur within 72 hours of ARDS.

Exclusion Criteria:

• Refractory hypotension (>2 µg/kg/min norepi or equivalent for >6h prior to randomization
• Core temp < 35.5°C except CRRT for ≥6h on day of randomization
• Bleeding (>3u blood products in <24h, surgery or IR day on day of randomization
• Platelets < 10K/mm 3 day of randomization
• Active hematologic malignancy
• Skin process that precludes cooling
• Moribund (<72 h predicted survival)
• Pre-morbid condition – unlikely 28d survival
• DNR (ie no CPR in the event of cardiac arrest)
• Unlikely to remain intubated for ≥48h
• Primary provider unwilling to participate
• Severe underlying lung disease (home O2, lung transplant; home vent (except OSA)
• BMI > 50 kg/m2
• NYHA class IV heart disease
• Acute coronary syndrome within 30d
• Cardiac arrest within 30d
• Burns > 20% body surface
• Severe chronic liver disease (C-P 12-15)
• Previously randomized in CHILL trial
• Enrolled in another intervention study
• On ECMO
• Missed ARDS window (72h)
• Missed NMB window (48h)
• Missed MV window (7d)