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Continuous NMB in PCAS

C

Chun Song Youn

Status and phase

Completed
Phase 2

Conditions

Out-of-hospital Cardiac Arrest

Treatments

Drug: Esmeron
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02790164
5-2016-B0001-00003

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

19+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 2 patient groups, including a placebo group

Rocuronium
Experimental group
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.
Treatment:
Drug: Esmeron
Usual Care
Placebo Comparator group
Description:
Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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