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NCT02790164 Clinical Trial

Continuous NMB in PCAS

Out-of-hospital Cardiac Arrest Clinical Trial

Official title:
Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02790164
Other study ID # 5-2016-B0001-00003
Secondary ID
Status Completed
Phase Phase 2
First received May 25, 2016
Last updated December 5, 2016
Start date May 2016

Study information
Verified date December 2016
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esmeron
Neuromuscular Blockade
• Saline
Normal Saline

Locations
Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (8)
Lead Sponsor Collaborator
Chun Song Youn Asan Medical Center, Chonnam National University Hospital, Hanil General Hospital, Hanyang University Guri Hospitall, The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Ulsan Universty Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lactate levels 24 hours after initiation of study drug 24 hours No
Secondary Lactate change over time 0, 12, 24, 36 hrs No
Secondary Survival in-hospital survival Duration of hospitalization, limit 180 days No
Secondary Good neurological outcome Modified Rankin Scale Duration of hospitalization, limit 180 days No
Secondary Length of intensive care unit stay Duration of ICU stay, limit 180 days No
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