Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
Status:
Terminated
Trial end date:
2020-06-02
Target enrollment:
Participant gender:
Summary
Phase II double blind (participants and investigator) placebo controlled randomized (1:1)
clinical trial of inhaled nitric oxide (iNO) 20 ppm administered over 12h beginning as soon
as possible but within 4 h of return of spontaneous circulation (ROSC) from out-of-hospital
cardiac arrest (OHCA). Planned enrollment is 180 subjects over 48 months at University of
Pittsburgh Medical Center (UPMC) Hospitals with randomization stratified in blocks of 8.
Recruitment will be performed under exception from informed consent (EFIC) to facilitate
early enrollment and treatment. The study will have a pre-specified safety analysis at the
mid-point (after 1 year or 60 patients whichever occurs first). Subjects will be screened by
members of the University of Pittsburgh post-cardiac arrest service (PCAS), all of whom will
serve as the study co-investigators, and the Research Coordinators. Notification of inclusion
under EFIC will be performed as soon as possible by a member of the study team generally to a
surrogate as the subjects will be comatose after OHCA.