Phase 3
N=1,008
Reevaluation Of Systemic Early Neuromuscular Blockade
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02509078 ↗Enrolled (actual)
1,008
Serious AEs
4.9%
Results posted
Aug 2019
Primary outcome: Primary: Hospital Mortality to Day 90 — 288; 289; 213; 216 Participants — p=0.93
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cisatracurium Besylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Mortality to Day 90 |
288; 289; 213; 216 | 0.93 |
| SECONDARY Mean Ventilator Free Days to Day 28 |
9.6; 9.9 | — |
| SECONDARY Mean Organ Failure Free Days to Day 28 |
12.4; 12.5 | — |
| SECONDARY ICU Free Days to Day 28 |
9.0; 9.4 | — |
| SECONDARY Mean Hospital Free Days to Days 28 |
5.7; 5.9 | — |
| SECONDARY Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) |
2.9; 2.4 | — |
| SECONDARY EuroQol (EQ-5D-5L): Health Related Quality of Life |
0.75; 0.77 | — |
| SECONDARY PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 |
21; 38 | — |
| SECONDARY MoCA-Blind: Montreal Cognitive Assessment |
23.3; 24.0 | — |
| SECONDARY Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) |
2.9; 2.4 | — |
| SECONDARY Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) |
2.9; 2.4 | — |
| SECONDARY EuroQol (EQ-5D-5L): Health Related Quality of Life |
0.75; 0.77 | — |
| SECONDARY EuroQol (EQ-5D-5L): Health Related Quality of Life |
0.75; 0.77 | — |
| SECONDARY MoCA-Blind: Montreal Cognitive Assessment |
23.3; 24.0 | — |
| SECONDARY MoCA-Blind: Montreal Cognitive Assessment |
23.3; 24.0 | — |
| SECONDARY PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 |
21; 38 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Presence of all of the following conditions for /= 8 cm H2O OR, if ABG not available, SaO2/FiO2 ratio that is equivalent to a PaO2/FiO2 /= 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
- 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 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)
Data sourced from ClinicalTrials.gov (NCT02509078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.