Continuous NMB in PCAS

NCT ID: NCT02790164

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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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

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Conditions

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Out-of-hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rocuronium

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.

Group Type EXPERIMENTAL

Esmeron

Intervention Type DRUG

Neuromuscular Blockade

Usual Care

Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Normal Saline

Interventions

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Esmeron

Neuromuscular Blockade

Intervention Type DRUG

Saline

Normal Saline

Intervention Type DRUG

Other Intervention Names

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Rocuronium

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role collaborator

Uijeongbu St. Mary's Hospital

UNKNOWN

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Hanil General Hospital

UNKNOWN

Sponsor Role collaborator

Ulsan Universty Hospital

UNKNOWN

Sponsor Role collaborator

Hanyang University Guri Hospitall

UNKNOWN

Sponsor Role collaborator

Chun Song Youn

OTHER

Sponsor Role lead

Responsible Party

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Chun Song Youn

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chun Song Youn, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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5-2016-B0001-00003

Identifier Type: -

Identifier Source: org_study_id