Continuous NMB in PCAS

Phase 2

Completed

• Conditions: Out-of-hospital Cardiac Arrest
• Interventions: Drug: Esmeron; Drug: Saline

• Registration Number: NCT02790164
• Lead Sponsor: Chun Song Youn

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-29
• Study First Posted: 2016-06-03
• Primary Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Adult (older than 19)
2. OHCA with sustained ROSC
3. Comatose (i.e., not following commands) following ROSC
4. Undergoing targeted temperature management (TTM)
5. Time of enrollment ≤ 6hrs from ROSC

Exclusion Criteria

1. Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3)
2. Traumatic etiology for cardiac arrest
3. Protected population (pregnant, prisoner)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium	Esmeron	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.
Usual Care	Saline	Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.

Primary Outcome Measures

Name	Time	Method
Lactate levels 24 hours after initiation of study drug	24 hours

Secondary Outcome Measures

Name	Time	Method
Lactate change over time	0, 12, 24, 36 hrs
Survival	Duration of hospitalization, limit 180 days	in-hospital survival
Good neurological outcome	Duration of hospitalization, limit 180 days	Modified Rankin Scale
Length of intensive care unit stay	Duration of ICU stay, limit 180 days

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of