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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCSF Fresno
Fresno, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSF Medical Center
San Francisco, California, United States
Stanford University Hospital
Stanford, California, United States
Medical Center of Aurora
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
Start Date
January 4, 2016
Primary Completion Date
July 3, 2018
Completion Date
April 4, 2019
Last Updated
August 13, 2019
1,008
ACTUAL participants
Cisatracurium Besylate
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07450846
NCT07414056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06701669