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Continuous NMB in PCAS

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Esmeron
Saline
Sponsored by
Chun Song Youn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rocuronium

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Lactate levels 24 hours after initiation of study drug

Secondary Outcome Measures

Lactate change over time
Survival
in-hospital survival
Good neurological outcome
Modified Rankin Scale
Length of intensive care unit stay

Full Information

First Posted
May 25, 2016
Last Updated
December 5, 2016
Sponsor
Chun Song Youn
Collaborators
The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Chonnam National University Hospital, Asan Medical Center, Hanil General Hospital, Ulsan Universty Hospital, Hanyang University Guri Hospitall
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1. Study Identification

Unique Protocol Identification Number
NCT02790164
Brief Title
Continuous NMB in PCAS
Official Title
Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chun Song Youn
Collaborators
The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Chonnam National University Hospital, Asan Medical Center, Hanil General Hospital, Ulsan Universty Hospital, Hanyang University Guri Hospitall

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rocuronium
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
Intervention Type
Drug
Intervention Name(s)
Esmeron
Other Intervention Name(s)
Rocuronium
Intervention Description
Neuromuscular Blockade
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
Lactate levels 24 hours after initiation of study drug
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Lactate change over time
Time Frame
0, 12, 24, 36 hrs
Title
Survival
Description
in-hospital survival
Time Frame
Duration of hospitalization, limit 180 days
Title
Good neurological outcome
Description
Modified Rankin Scale
Time Frame
Duration of hospitalization, limit 180 days
Title
Length of intensive care unit stay
Time Frame
Duration of ICU stay, limit 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Song Youn, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

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Continuous NMB in PCAS

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