Neuromuscular Blockade for Post-Cardiac Arrest Care
NMB_in_CA
2 other identifiers
interventional
83
1 country
5
Brief Summary
The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Longer than P75 for phase_2
5 active sites
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
First Submitted
Initial submission to the registry
September 24, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2019
CompletedResults Posted
Study results publicly available
January 29, 2021
CompletedJanuary 29, 2021
January 1, 2021
4.7 years
September 24, 2014
June 28, 2020
January 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Lactate Over 24 Hours
Change in median serum lactate level between enrollment and 24-hours after the receipt of study drug. A negative number indicates that the lactate levels were lower at 24 hours compared to their level at receipt of study drug.
24 hours
Change in Lactate Over 24 Hours: Effect Estimate
Interaction between allocated treatment and time: ratio of geometric mean differences over 24 hours in log lactate values between the two groups.
24 hours
Secondary Outcomes (6)
Time ROSC to Target Temperature
Duration of hospitalization, limit 180 days
Length of Intensive Care Unit (ICU) Stay
Length of Stay Truncated at 28 Days
Mechanical Ventilation Duration
Duration of hospitalization, limit 180 days
Survival
Duration of hospitalization, limit 180 days
Number of Participants With Rankin Score ≤3
Duration of hospitalization, limit 180 days
- +1 more secondary outcomes
Study Arms (2)
Rocuronium
EXPERIMENTALPatients will receive a bolus dose of 1 mg/kg, then a continuous intravenous (IV) infusion as per standard intensive care unit practice. Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).
Usual Care
PLACEBO COMPARATORPatients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
Interventions
Eligibility Criteria
You may qualify if:
- Adult (≥ 18 years)
- Cardiac arrest with sustained return of spontaneous circulation (ROSC)
- Comatose (i.e., not following commands) following ROSC
- Undergoing targeted temperature management (TTM)
- Time of enrollment ≤ 6 hours from initiation of targeted temperature management
- Serum Lactate ≥2
You may not qualify if:
- Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
- Traumatic etiology of the cardiac arrest
- Protected population (pregnant, prisoner)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- University of Pittsburgh Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
- University of Alabama at Birminghamcollaborator
- Beaumont Hospitalcollaborator
Study Sites (5)
Michael Kurz
Birmingham, Alabama, 35294, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Robert Swor
Royal Oak, Michigan, 48073, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Moskowitz A, Andersen LW, Rittenberger JC, Swor R, Seethala RR, Kurz MC, Berg KM, Chase M, Cocchi MN, Grossestreuer AV, Liu X, Holmberg MJ, Callaway CW, Donnino MW. Continuous Neuromuscular Blockade Following Successful Resuscitation From Cardiac Arrest: A Randomized Trial. J Am Heart Assoc. 2020 Sep;9(17):e017171. doi: 10.1161/JAHA.120.017171. Epub 2020 Aug 27.
PMID: 32851921DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mike Donnino
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W Donnino, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Donnino MD
Study Record Dates
First Submitted
September 24, 2014
First Posted
October 9, 2014
Study Start
October 1, 2014
Primary Completion
May 29, 2019
Study Completion
May 29, 2019
Last Updated
January 29, 2021
Results First Posted
January 29, 2021
Record last verified: 2021-01