Reevaluation Of Systemic Early Neuromuscular Blockade

Completed · Phase 3

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT02509078

Run by

Massachusetts General Hospital

People needed

1008

Starts

2016-01-04

Expected to finish

2019-04-04

Last updated by the study team

2019-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

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
• Previous hypersensitivity or anaphylactic reaction to cisatracurium
• Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair spontaneous ventilation (Appendix A2)
• Neurologic conditions undergoing treatment for intracranial hypertension
• Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP
• >120 hours of mechanical ventilation
• P/F < 200 mmHg at the time of randomization (if available)

Where it is running

• 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
• University Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Vincent's Hospital — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mt. Sinai Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wesley Long Hospital — Greensboro, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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