Continuous NMB in PCAS

December 5, 2016 updated by: Chun Song Youn

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Saline
Normal Saline
Experimental: 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.
Drug: Esmeron
Neuromuscular Blockade
Other Names:
  • Rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lactate levels 24 hours after initiation of study drug
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chun Song Youn

Collaborators

Asan Medical Center
Chonnam National University Hospital
The Catholic University of Korea
Uijeongbu St. Mary's Hospital
Hanil General Hospital
Ulsan Universty Hospital
Hanyang University Guri Hospitall

Investigators

  • Principal Investigator: Chun Song Youn, MD, Seoul st. mary's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 29, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-2016-B0001-00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Out-of-hospital Cardiac Arrest

Clinical Trials on Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe