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OpenTrials
Completed

NCT Number: NCT02790164

Continuous NMB in PCAS

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Esmeron

Drug

Neuromuscular Blockade

Other names: Rocuronium

Saline

Drug

Normal Saline

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

    Time frame: Duration of hospitalization, limit 180 days

    in-hospital survival

  3. Good neurological outcome

    Time frame: Duration of hospitalization, limit 180 days

    Modified Rankin Scale

  4. Length of intensive care unit stay

    Time frame: Duration of ICU stay, limit 180 days

Sponsors and collaborators

Lead sponsor

Chun Song Youn

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
First posted
Jun 3, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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