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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
July 24, 2015
July 27, 2015
May 25, 2017
December 2015
September 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02509078 on ClinicalTrials.gov Archive Site
  • 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?
  • Ventilator Free Days to day 28 [ Time Frame: 28 days after randomization ]
  • Organ Failure Free days to day 28 [ Time Frame: 28 days after randomization ]
  • ICU Free Days to day 28 [ Time Frame: 28 days after randomization ]
  • Hospital Free Days to days 28 [ Time Frame: 28 days after randomization ]
Not Provided
Not Provided
 
Reevaluation Of Systemic Early Neuromuscular Blockade
Reevaluation Of Systemic Early Neuromuscular Blockade
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 .

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
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
  • Active Comparator: Early Neuromuscular Blockade (NMB)
    Patients will receive cisastracurium besylate for the first 48 hours of the trial.
    Intervention: Drug: cisastracurium besylate
  • No Intervention: Control: No Routine Early NMB
    Use of non-study NMB will be discouraged.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1408
October 2018
September 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Katie Oldmixon, RN 617 726-4777 coldmixon@mgh.harvard.edu
Contact: Nancy Ringwood, BSN 617 724-9836 nringwood@mgh.harvard.edu
United States
 
 
NCT02509078
PETAL01ROSE
1U01HL123009-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
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.
David Alan Schoenfeld, Massachusetts General Hospital
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: David A. Schoenfeld, PhD Massachusetts General Hospital
Massachusetts General Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP