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CompletedNCT02790164Updated Dec 7, 2016

Continuous NMB in PCAS

A Phase 2 interventional study of Esmeron and Saline in Out-of-hospital Cardiac Arrest, sponsored by Chun Song Youn. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.

Sponsored by Chun Song Youn · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Out-of-hospital Cardiac Arrest
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 81 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

This is the only study on the registry with Chun Song Youn as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugEsmeron

    Neuromuscular Blockade

    Also known as: Rocuronium

  • DrugSaline

    Normal Saline

06

What researchers measure

Primary outcomes

  1. Lactate levels 24 hours after initiation of study drug

    Time frame: 24 hours

Secondary outcomes

  1. Lactate change over time

    Time frame: 0, 12, 24, 36 hrs

  2. Survival

    in-hospital survival

    Time frame: Duration of hospitalization, limit 180 days

  3. Good neurological outcome

    Modified Rankin Scale

    Time frame: Duration of hospitalization, limit 180 days

  4. Length of intensive care unit stay

    Time frame: Duration of ICU stay, limit 180 days

07

Study locations

1 site
  • Seoul St. Mary's Hospital
    Seoul, 06591, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02790164
Lead 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
Responsible party
Chun Song Youn (Professor, Seoul St. Mary's Hospital) — Sponsor-investigator
First posted
Jun 3, 2016
Start date
May 2016
Primary completion
Nov 2016
Last update
Dec 7, 2016

Study contacts

Chun Song Youn, MD
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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