Reevaluation Of Systemic Early Neuromuscular Blockade
ROSE
2 other identifiers
interventional
1,008
1 country
44
Brief Summary
This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Typical duration for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedStudy Start
First participant enrolled
January 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 13, 2019
July 1, 2019
2.5 years
July 24, 2015
June 20, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Mortality to Day 90
The percentage of subjects alive at study day 90. Those subjects discharged home prior to day 90 were counted as alive at day 90.
90 days after randomization
Secondary Outcomes (15)
Mean Ventilator Free Days to Day 28
28 days after randomization
Mean Organ Failure Free Days to Day 28
28 days after randomization
ICU Free Days to Day 28
28 days after randomization
Mean Hospital Free Days to Days 28
28 days after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
3 months after randomization
- +10 more secondary outcomes
Study Arms (2)
Early Neuromuscular Blockade (NMB)
ACTIVE COMPARATORPatients will receive cisatracurium besylate for the first 48 hours of the trial.
Control: No Routine Early NMB
NO INTERVENTIONUse of non-study NMB will be discouraged.
Interventions
Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Presence of all of the following conditions for \< 48 hours:
- i. PaO2/FiO2 \< 150 with PEEP \>/= 8 cm H2O OR, if ABG not available, SaO2/FiO2 ratio that is equivalent to a PaO2/FiO2 \< 150 with PEEP \>/= 8 cm H2O , and a confirmatory SaO2/FiO2 ratio that is again equivalent 1-6 hours later
- ii. Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.
- iii. Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
You may not qualify if:
- Lack of informed consent
- Continuous neuromuscular blockade at enrollment
- Known pregnancy
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 \> 60 mm Hg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
- Actual body weight exceeding 1 kg per centimeter of height
- Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)
- Bone marrow transplantation within the last 1 year
- Expected duration of mechanical ventilation of \< 48 hours
- Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs
- Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 from CPR conclusion
- Diffuse alveolar hemorrhage from vasculitis
- Burns \> 70% total body surface
- Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
UCSF Fresno
Fresno, California, 93701, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Stanford University Hospital
Stanford, California, 94305, United States
Medical Center of Aurora
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, 46220, United States
University Medical Center
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
St. Vincent's Hospital
Worcester, Massachusetts, 01608, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Medical Center
Detroit, Michigan, 48025, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Wesley Long Hospital
Greensboro, North Carolina, 27403, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Summa Akron City Hospital
Akron, Ohio, 44304, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
UPMC Presbyterian/Mercy/Shadyside
Pittsburgh, Pennsylvania, 15261, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37221, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
University Hospital
Salt Lake City, Utah, 84132, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
University or Virginia Health System
Charlottesville, Virginia, 22903, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98104, United States
Swedish Hospital Cherry Hill
Seattle, Washington, 98122, United States
Swedish Hospital First Hill
Seattle, Washington, 98122, United States
Related Publications (3)
National Heart, Lung, and Blood Institute PETAL Clinical Trials Network; Moss M, Huang DT, Brower RG, Ferguson ND, Ginde AA, Gong MN, Grissom CK, Gundel S, Hayden D, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Khan A, Liu KD, Talmor D, Thompson BT, Ulysse CA, Yealy DM, Angus DC. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019 May 23;380(21):1997-2008. doi: 10.1056/NEJMoa1901686. Epub 2019 May 19.
PMID: 31112383DERIVEDSjoding MW, Schoenfeld DA, Brown SM, Hough CL, Yealy DM, Moss M, Angus DC, Iwashyna TJ; NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):110-117. doi: 10.1513/AnnalsATS.201608-585OC.
PMID: 27788018DERIVEDHuang DT, Angus DC, Moss M, Thompson BT, Ferguson ND, Ginde A, Gong MN, Gundel S, Hayden DL, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Liu KD, Talmor DS, Yealy DM; Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators. Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):124-133. doi: 10.1513/AnnalsATS.201608-629OT.
PMID: 27779896DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katie Oldmixon
- Organization
- Mass General Hospital (PETAL Clinical Coordinating Center)
Study Officials
- PRINCIPAL INVESTIGATOR
David A. Schoenfeld, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator PETAL CCC
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 27, 2015
Study Start
January 4, 2016
Primary Completion
July 3, 2018
Study Completion
April 4, 2019
Last Updated
August 13, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
Data will be collected electronically and stored at the Clinical Coordinating Center at MGH. A de-identified database of all data will be available for use 3 years after the primary publication. Data can be accessed at that point via the NHLBI BioLINCC data repository.