Reevaluation Of Systemic Early Neuromuscular Blockade
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,008
- Locations
- 44
- Primary Endpoint
- Hospital Mortality to Day 90
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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)
Arms & Interventions
Early Neuromuscular Blockade (NMB)
Patients will receive cisatracurium besylate for the first 48 hours of the trial.
Intervention: Cisatracurium Besylate (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Mean Organ Failure Free Days to Day 28(28 days after randomization)
- ICU Free Days to Day 28(28 days after randomization)
- EuroQol (EQ-5D-5L): Health Related Quality of Life(12 months after randomization)
- Mean Hospital Free Days to Days 28(28 days after randomization)
- Mean Ventilator Free Days to Day 28(28 days after randomization)
- Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)(12 months after randomization)
- PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45(12 months after randomization)
- MoCA-Blind: Montreal Cognitive Assessment(12 months after randomization)
Investigators
Boyd Taylor Thompson
Prinicipal Investigator PETAL CCC
Massachusetts General Hospital