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Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE)

This study is currently recruiting participants.
Verified May 2017 by David Alan Schoenfeld, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02509078
First Posted: July 27, 2015
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Alan Schoenfeld, Massachusetts General Hospital
  Purpose
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 .

Condition Intervention Phase
Acute Respiratory Distress Syndrome Drug: cisastracurium besylate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reevaluation Of Systemic Early Neuromuscular Blockade

Resource links provided by NLM:


Further study details as provided by David Alan Schoenfeld, Massachusetts General Hospital:

Primary Outcome Measures:
  • Hospital Mortality to day 90 [ Time Frame: 90 days after randomization ]
    The percentage of subjects alive at study day 90. Those subjects discharged home prior to day 90 were counted as alive at day 90.


Secondary Outcome Measures:
  • Mean Ventilator Free Days to day 28 [ Time Frame: 28 days after randomization ]
    Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

  • Mean Organ Failure Free days to day 28 [ Time Frame: 28 days after randomization ]
    A patient will be considered failure free on each day alive with SOFA scores for all organ systems below 2.

  • ICU Free Days to day 28 [ Time Frame: 28 days after randomization ]
    ICU free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day).

  • Mean Hospital Free Days to days 28 [ Time Frame: 28 days after randomization ]
    Hospital free days are days alive post hospital discharge through day 28. Patients who die on or prior to day 28 are assigned zero hopsital free days.

  • Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) [ Time Frame: 12 months after randomization ]
    Assesses whether individual can living independantly

  • EuroQol (EQ-5D-5L): Health Related Quality of Life [ Time Frame: 12 months after randomization ]
    Using a standardized scale, do health reasons limit the person's ability to enjoy their life?

  • PTSS-14: Post-traumatic Stress-like Symptoms [ Time Frame: 12 months after randomization ]
    Does the patient have symptoms of anxiety and stress from their ICU stay?

  • MoCA-Blind: Montreal Cognitive Assessment [ Time Frame: 12 months after randomization ]
    How clearly can patient think and recall things?


Estimated Enrollment: 1408
Study Start Date: December 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Neuromuscular Blockade (NMB)
Patients will receive cisastracurium besylate for the first 48 hours of the trial.
Drug: cisastracurium besylate
Patients randomized to the early neuromuscular blockade arm will receive a cisastracurium 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.
Other Name: Nimbex
No Intervention: Control: No Routine Early NMB
Use of non-study NMB will be discouraged.

Detailed Description:

PRIMARY OBJECTIVE::

To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS, in comparison to a control group with no routine early neuromuscular blockade (NMB).

PRIMARY HYPOTHESIS:

Early neuromuscular blockade will improve mortality prior to discharge home before day 90, in patients with moderate-severe ARDS.

The trial will accrue a maximum of 1408 patients. Patients will be recruited from the emergency departments, intensive care units and other acute care areas of the PETAL Network Clinical Centers and randomized to the active (NMB) or control. The overall strategy is to screen, consent, and enroll early, every newly intubated, acutely ill or post-operative, eligible patient at each site, using clinically obtained pulse oximetry and blood gases.

By preventing active expiration, and/or patient ventilator dyssynchrony, neuromuscular blockade may create a more homogenous distribution of airway pressures and tidal volumes, preventing barotrauma/volutrauma and "atelectrauma" resulting in less ventilator-induced lung injury.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age > 18 years
  2. 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.

Patients must be enrolled within 48 hours of meeting inclusion criteria.

Exclusion Criteria:

  1. Lack of informed consent
  2. Continuous neuromuscular blockade at enrollment
  3. Known pregnancy
  4. Currently receiving ECMO therapy
  5. Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting
  6. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
  7. Actual body weight exceeding 1 kg per centimeter of height
  8. Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)
  9. Bone marrow transplantation within the last 1 year
  10. Expected duration of mechanical ventilation of < 48 hours
  11. Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs
  12. Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 from CPR conclusion
  13. Diffuse alveolar hemorrhage from vasculitis
  14. Burns > 70% total body surface
  15. Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol
  16. Previous hypersensitivity or anaphylactic reaction to cisatracurium
  17. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair spontaneous ventilation (Appendix A2)
  18. Neurologic conditions undergoing treatment for intracranial hypertension
  19. Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP
  20. >120 hours of mechanical ventilation
  21. P/F < 200 mmHg at the time of randomization (if available)
  Contacts and Locations
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): NCT02509078


Contacts
Contact: Katie Oldmixon, RN 617 726-4777 coldmixon@mgh.harvard.edu
Contact: Nancy Ringwood, BSN 617 724-9836 nringwood@mgh.harvard.edu

  Hide Study Locations
Locations
United States, California
UCSF Fresno Recruiting
Fresno, California, United States, 93701
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Stanford University Hospital Recruiting
Stanford, California, United States, 94305
United States, Colorado
Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Rose Medical Center Withdrawn
Denver, Colorado, United States, 80220
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
United States, Indiana
Indiana University Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46220
United States, Louisiana
Oschner Medical Center-Kenner Withdrawn
Kenner, Louisiana, United States, 70065
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Oschner Medical Center Withdrawn
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
St. Vincent's Hospital Recruiting
Worcester, Massachusetts, United States, 01608
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48025
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, New York
Mt. Sinai Hospital Recruiting
New York, New York, United States, 10029
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
United States, North Carolina
Moses Cone Hospital Withdrawn
Greensboro, North Carolina, United States, 27401
Wesley Long Hospital Terminated
Greensboro, North Carolina, United States, 27403
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital Terminated
Akron, Ohio, United States, 44304
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Portland Medical Center Withdrawn
Portland, Oregon, United States, 97213
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
UPMC Presbyterian/Mercy/Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15261
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37221
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
McKay-Dee Hospital Recruiting
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center Recruiting
Provo, Utah, United States, 84604
University Hospital Recruiting
Salt Lake City, Utah, United States, 84132
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
United States, Virginia
University or Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98104
Swedish Hospital Cherry Hill Not yet recruiting
Seattle, Washington, United States, 98122
Swedish Hospital First Hill Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: David A. Schoenfeld, PhD Massachusetts General Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Alan Schoenfeld, Prinicipal Investigator PETAL CCC, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02509078     History of Changes
Other Study ID Numbers: PETAL01ROSE
1U01HL123009-01 ( U.S. NIH Grant/Contract )
First Submitted: July 24, 2015
First Posted: July 27, 2015
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by David Alan Schoenfeld, Massachusetts General Hospital:
ARDS
neuromuscular blocker
cisatracurium

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury