Status:
WITHDRAWN
Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Respiratory Distress Syndrome, Adult
Sars-CoV2
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 optimi...
Detailed Description
Background: Despite recent advances in supportive care for patients with acute respiratory distress syndrome (ARDS), mortality remains \>40%. Fever worsens and hypothermia mitigates animal models of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Enrollment
- COVID-19 diagnosed by PCR within 3 weeks
- men and women
- any race/ethnicity
- 18-65 years of age
- endotracheal tube or tracheostomy in place and mechanically ventilated for \< 7 days;
- radiologic evidence of bilateral pulmonary infiltrates not fully explained by hydrostatic pulmonary edema
- access to an LAR to provide consent (remote consent is permissible).
- Additional inclusion criteria required for randomization:
- meet all inclusion/exclusion criteria for enrollment
- have a P/F ratio \<200 with PEEP ≥8 cm H2O either from ABG or imputed from SpO2 as described by Brown et al (Chest 2016; 150:307).
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03376854
Start Date
May 1 2018
End Date
April 27 2021
Last Update
April 30 2021
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201