Neuromuscular Blockade for Post-Cardiac Arrest Care

Condition(s) targeted: Cardiac Arrest

Intervention: Rocuronium (Drug); Normal Saline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Overall contact:
Michael W Donnino, MD, Phone: 671-754-2341, Email: mdonnino@bidmc.harvard.edu

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.

Official title: Neuromuscular Blockade for Post-Cardiac Arrest Care

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome: Lactate levels 24 hours after initiation of study drug

Secondary outcome:

Lactate change over time

Survival

Good neurological outcome

Length of intensive care unit (ICU) stay

Detailed 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 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 trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after ROSC. We will enroll adult, comatose OHCA patients with return of spontaneous circulation and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium (or cisatracurium) 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, in-hospital mortality, and good neurological outcome. We will perform at sub-study of inflammatory markers and oxygen consumption at certain sites depending on additional funding that is currently pending.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult (≥ 18 years)

- Out-of-hospital cardiac arrest with sustained return of spontaneous circulation

(ROSC)

- Comatose (i. e., not following commands) following ROSC

- Undergoing targeted temperature management

- Time of enrollment ≤ 6 hours from ROSC

- Capacity to breathe above set ventilator rate

Exclusion Criteria:

- Pre-existing dementia, severe brain injury, or dependence on others for activities of

daily living (i. e. a modified Rankin scale score of 4 or higher)

- Traumatic etiology of the cardiac arrest

- Protected population (pregnant, prisoner)

Michael W Donnino, MD, Phone: 671-754-2341, Email: mdonnino@bidmc.harvard.edu

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Michael W Donnino, MD, Phone: 617-754-2295, Email: mdonnino@bidmc.harvard.edu
Julia L Balkema, Phone: 617-754-2881, Email: jbalkema@bidmc.harvard.edu
Michael W Donnino, MD, Principal Investigator

Brigham and Women's Hospital, Boston, Massachusetts 02215, United States; Recruiting
Raghu Seethla, MD

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Not yet recruiting
Jon C Rittenberger, MD, Principal Investigator

Starting date: October 2014
Last updated: January 7, 2015