Continuous NMB in PCAS | NCT02790164

Studies
Continuous NMB in PCAS

NCT02790164

Sponsor

Chun Song Youn

Status

Completed

Last Update Posted

Dec 7, 2016Estimated

Enrollment

81Actual

Phase

Phase 2

Conditions

Out-of-hospital Cardiac Arrest

Interventions

Esmeron
Saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Not provided

First Submitted Date

May 25, 2016

First Submission Date that Met QC Criteria

May 29, 2016

First Posted Date

Jun 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2016

Last Update Posted Date

Dec 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Song Youn, Professor, Seoul St. Mary's HospitalSponsor-Investigator

Lead Sponsor

Chun Song YounOTHER

Collaborators

Name	Class
The Catholic University of Korea	OTHER
Uijeongbu St. Mary's Hospital	UNKNOWN
Chonnam National University Hospital	OTHER
Asan Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Esmeron	Drug	Neuromuscular Blockade	Rocuronium	Rocuronium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lactate levels 24 hours after initiation of study drug		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Lactate change over time		0, 12, 24, 36 hrs
Survival	in-hospital survival	Duration of hospitalization, limit 180 days

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chun Song Youn, MD	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's Hospital		Seoul	Seoul	06591	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided