NCT02790164

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

May 25, 2016

Last Update Submit

December 5, 2016

Conditions

Out-of-hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Lactate levels 24 hours after initiation of study drug

    24 hours

Secondary Outcomes (4)

  • Lactate change over time

    0, 12, 24, 36 hrs

  • Survival

    Duration of hospitalization, limit 180 days

  • Good neurological outcome

    Duration of hospitalization, limit 180 days

  • Length of intensive care unit stay

    Duration of ICU stay, limit 180 days

Study Arms (2)

Rocuronium

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

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

Interventions

EsmeronDRUG

Neuromuscular Blockade

Also known as: Rocuronium
Rocuronium
SalineDRUG

Normal Saline

Usual Care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

RocuroniumSodium Chloride

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Chun Song Youn, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

KR(1)