NCT02790164CompletedPhase 2
Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial
Chun Song Youn1 site in 1 country81 target enrollmentStarted: May 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Lactate levels 24 hours after initiation of study drug
Study Overview
Brief Summary
The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (older than 19)
- •OHCA with sustained ROSC
- •Comatose (i.e., not following commands) following ROSC
- •Undergoing targeted temperature management (TTM)
- •Time of enrollment ≤ 6hrs from ROSC
Exclusion Criteria
- •Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3)
- •Traumatic etiology for cardiac arrest
- •Protected population (pregnant, prisoner)
Arms & Interventions
Rocuronium
Experimental
Patients will receive a bolus dose of 0.6 mg/kg, then a continuous I.V. infusion of 0.3-0.6 mg/kg/hr as per standard intensive care unit practice.
Intervention: Esmeron (Drug)
Usual Care
Placebo Comparator
Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Lactate levels 24 hours after initiation of study drug
Time Frame: 24 hours
Secondary Outcomes
- Lactate change over time(0, 12, 24, 36 hrs)
- Survival(Duration of hospitalization, limit 180 days)
- Good neurological outcome(Duration of hospitalization, limit 180 days)
- Length of intensive care unit stay(Duration of ICU stay, limit 180 days)
Investigators
Chun Song Youn
Professor
Seoul St. Mary's Hospital
Study Sites (1)
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