Phase 2
N=83
Neuromuscular Blockade for Post-Cardiac Arrest Care
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT02260258 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Lactate Over 24 Hours — -2.2; -2.3 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rocuronium (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lactate Over 24 Hours |
-2.2; -2.3 | — |
| PRIMARY Change in Lactate Over 24 Hours: Effect Estimate |
1.3 | — |
| SECONDARY Time ROSC to Target Temperature |
6.8; 8.3 | 0.82 |
| SECONDARY Length of Intensive Care Unit (ICU) Stay |
6.0; 4.0; 9.0; 5.0 | 0.09 |
| SECONDARY Mechanical Ventilation Duration |
102.0; 82.7; 126.3; 66.9 | 0.18 |
| SECONDARY Survival |
14; 14 | 0.63 |
| SECONDARY Number of Participants With Rankin Score ≤3 |
11; 9 | 0.35 |
| SECONDARY Muscle Weakness Score |
30; 30 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02260258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.