Reevaluation Of Systemic Early Neuromuscular Blockade

Trial ID or NCT#

NCT02509078

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Reevaluation Of Systemic Early Neuromuscular Blockade

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Exclusion Criteria:
  1. 1. Lack of informed consent 2. Continuous neuromuscular blockade at enrollment 3. Known pregnancy 4. Currently receiving ECMO therapy 5. Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting 6. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing 7. Actual body weight exceeding 1 kg per centimeter of height 8. Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2) 9. Bone marrow transplantation within the last 1 year 10. Expected duration of mechanical ventilation of < 48 hours 11. Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs 12. Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 from CPR conclusion 13. Diffuse alveolar hemorrhage from vasculitis 14. Burns > 70% total body surface 15. Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol 16. Previous hypersensitivity or anaphylactic reaction to cisatracurium 17. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair spontaneous ventilation (Appendix A2) 18. Neurologic conditions undergoing treatment for intracranial hypertension 19. Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP 20. >120 hours of mechanical ventilation 21. P/F < 200 mmHg at the time of randomization (if available)
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Investigator(s)

Joseph Levitt, MD, MS
Joseph Levitt, MD, MS
Pulmonary critical care specialist, Pulmonologist, Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)
Matthew Strehlow
Matthew Strehlow
Emergency medicine doctor
Professor of Emergency Medicine

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Contact

SPECTRUM
6507236576

View on ClinicalTrials.gov