Neuromuscular Blockade for Post-Cardiac Arrest Care (NMB_in_CA)

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Cardiac Arrest

Treatments: Drug: Normal Saline; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02260258

2014P000204

14GRNT20010002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Out-of-hospital cardiac arrest (OHCA) occurs in more than 300,000 patients in the United States each year with an estimated mortality of greater than 90%. Unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. Neuromuscular blockade (NMB) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. However, usage of NMB remains controversial and current American Heart Association (AHA) recommendations are to minimize utilization. Recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from NMB and an excellent safety profile. Furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of NMB is associated with improved survival. Given this, we hypothesize that continuous NMB will be beneficial in post-arrest patients. In order to test this hypothesis, we propose a multi-center, randomized, open-label, phase II trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after return of spontaenous circulation (ROSC). We will enroll adult, comatose OHCA patients with ROSC and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. Previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. We have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. Secondarily we will evaluate clinical endpoints including length of stay (LOS), in-hospital mortality, and good neurological outcome. We will perform a sub-study of inflammatory markers and oxygen consumption.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups, including a placebo group

Rocuronium

Experimental group

Description:

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).

Treatment:

Drug: Rocuronium

Usual Care

Placebo Comparator group

Description:

Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.

Treatment:

Drug: Normal Saline