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Neuromuscular Blockade for Post-Cardiac Arrest Care (NMB_in_CA)

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ClinicalTrials.gov Identifier: NCT02260258
Recruitment Status : Recruiting
First Posted : October 9, 2014
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
University of Pittsburgh Medical Center
Brigham and Women's Hospital
University of Alabama at Birmingham
Beaumont Hospital
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: Rocuronium Drug: Normal Saline Phase 2

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 American Heart Association 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 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Neuromuscular Blockade for Post-Cardiac Arrest Care
Study Start Date : October 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Rocuronium

Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. 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).

Drug: Rocuronium
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.
Drug: Normal Saline
Normal Saline




Primary Outcome Measures :
  1. Lactate levels 24 hours after initiation of study drug [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Lactate change over time [ Time Frame: (0, 12, 24, 36-hours) ]
  2. Survival [ Time Frame: Duration of hospitalization, limit 180 days ]
    In-hospital survival

  3. Good neurological outcome [ 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.

    Good and bad neurological outcome will be defined as a score of 0-3 and 4-6 respectively.


  4. Length of intensive care unit (ICU) stay [ Time Frame: Duration of ICU stay, limit 180 days ]
    Time from study drug to ICU discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 score of 4 or higher)
  • Traumatic etiology of the cardiac arrest
  • Protected population (pregnant, prisoner)

Information from the National Library of Medicine

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


Contacts
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Contact: Michael W Donnino, MD 617-754-2341 mdonnino@bidmc.harvard.edu
Contact: Sarah E Ganley 617-754-2881 sganley@bidmc.harvard.edu

Locations
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United States, Alabama
Michael Kurz Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michael C Kurz, M.D., M.S.         
Contact: Joel Rodgers         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD    617-754-2295    mdonnino@bidmc.harvard.edu   
Contact: Sarah Ganley    617-754-2881    sganley@bidmc.harvard.edu   
Principal Investigator: Michael W Donnino, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Raghu Seethla, MD         
United States, Michigan
Robert Swor Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kelly N Sawyer, M.D.         
Contact: Mara Branoff, RN BSN         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Jon C Rittenberger, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
University of Pittsburgh Medical Center
Brigham and Women's Hospital
University of Alabama at Birmingham
Beaumont Hospital
Investigators
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Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  Study Documents (Full-Text)

Documents provided by Michael Donnino, Beth Israel Deaconess Medical Center:
Statistical Analysis Plan  [PDF] June 7, 2019


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Responsible Party: Michael Donnino, Michael Donnino MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02260258     History of Changes
Other Study ID Numbers: 2014P000204
14GRNT20010002 ( Other Grant/Funding Number: American Heart Association )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
Cardiac Arrest, NMB, Neuromuscular Blockade, Rocuronium

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs