Neuromuscular Blockade for Post-Cardiac Arrest Care (NMB_in_CA)
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|ClinicalTrials.gov Identifier: NCT02260258|
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Drug: Rocuronium Drug: Normal Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Neuromuscular Blockade for Post-Cardiac Arrest Care|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 29, 2019|
|Actual Study Completion Date :||May 29, 2019|
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).
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.
Drug: Normal Saline
- 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.
- 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.
- Time ROSC to Target Temperature [ Time Frame: Duration of hospitalization, limit 180 days ]Time from return of spontaneous circulation to target temperature
- Length of Intensive Care Unit (ICU) Stay [ Time Frame: Length of Stay Truncated at 28 Days ]Length of stay in ICU
- Mechanical Ventilation Duration [ Time Frame: Duration of hospitalization, limit 180 days ]Mechanical Ventilation Duration in Hours
- Survival [ Time Frame: Duration of hospitalization, limit 180 days ]In-hospital survival
- 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:
- 0: No symptoms
- 1: No significant disability (able to carry out all usual activities, despite some symptoms)
- 2: Slight disability (able to look after own affairs without assistance, but unable to carry out all previous activities)
- 3: Moderate disability (requires some help, but able to walk unassisted)
- 4: Moderately severe disability (unable to attend to own bodily needs without assistance, and unable to walk unassisted)
- 5: Severe disability (requires constant nursing care and attention, bedridden, incontinent)
- 6: Dead.
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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260258
|United States, Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Royal Oak, Michigan, United States, 48073|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michael W Donnino, MD||Beth Israel Deaconess Medical Center|