Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS
Status:
Withdrawn
Trial end date:
2021-04-27
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore