Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE)
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|ClinicalTrials.gov Identifier: NCT02509078|
Recruitment Status : Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Drug: cisastracurium besylate||Phase 3|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1006 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reevaluation Of Systemic Early Neuromuscular Blockade|
|Actual Study Start Date :||January 4, 2016|
|Estimated Primary Completion Date :||May 4, 2018|
|Estimated Study Completion Date :||April 4, 2019|
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.
- 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.
- 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?
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
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|Principal Investigator:||David A. Schoenfeld, PhD||Massachusetts General Hospital|