- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260258
Neuromuscular Blockade for Post-Cardiac Arrest Care (NMB_in_CA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Michael Kurz
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- Robert Swor
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rocuronium
Patients 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). |
Neuromuscular Blockade
|
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.
|
Normal Saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lactate Over 24 Hours
Time Frame: 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
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time ROSC to Target Temperature
Time Frame: Duration of hospitalization, limit 180 days
|
Time from return of spontaneous circulation to target temperature
|
Duration of hospitalization, limit 180 days
|
Length of Intensive Care Unit (ICU) Stay
Time Frame: Length of Stay Truncated at 28 Days
|
Length of stay in ICU
|
Length of Stay Truncated at 28 Days
|
Mechanical Ventilation Duration
Time Frame: Duration of hospitalization, limit 180 days
|
Mechanical Ventilation Duration in Hours
|
Duration of hospitalization, limit 180 days
|
Survival
Time Frame: Duration of hospitalization, limit 180 days
|
In-hospital survival
|
Duration of hospitalization, limit 180 days
|
Number of Participants With Rankin Score ≤3
Time Frame: Duration of hospitalization, limit 180 days
|
Modified Rankin scale to assess neurological outcome at discharge. The scale ranges from 0 to 6, and is used for measuring the performance of daily activities. The score is as follows:
Higher cores represent worse outcomes. Good and bad neurological outcome will be defined as a score of 0-3 and 4-6 respectively. This outcome reports the number of patients with a good neurological outcome( modified Rankin score ≤ 3) |
Duration of hospitalization, limit 180 days
|
Muscle Weakness Score
Time Frame: Duration of hospitalization, limit 180 days
|
Medical Research Council Scale : Measured for 6 muscle groups (3 in the upper limbs and 3 in the lower limbs). Maximum score is 30 (grade 5 for each group) and minimum is 0 (grade 0 for each group). If muscle group strength was not symmetric bilaterally, higher measurement used. Higher scores indicate better outcomes. Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance. Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane. Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle. Grade 0: No movement is observed |
Duration of hospitalization, limit 180 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P000204
- 14GRNT20010002 (Other Grant/Funding Number: American Heart Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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