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 consent2. Continuous neuromuscular blockade at enrollment3. Known pregnancy4. Currently receiving ECMO therapy5. Chronic respiratory failure defined as PaCO2 \> 60 mm Hg in the outpatient setting6. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing7. Actual body weight exceeding 1 kg per centimeter of height8. Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)9. Bone marrow transplantation within the last 1 year10. Expected duration of mechanical ventilation of \< 48 hours11. Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs12. Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 from CPR conclusion13. Diffuse alveolar hemorrhage from vasculitis14. Burns \> 70% total body surface15. Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol16. Previous hypersensitivity or anaphylactic reaction to cisatracurium17. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair spontaneous ventilation (Appendix A2)18. Neurologic conditions undergoing treatment for intracranial hypertension19. Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP20. \>120 hours of mechanical ventilation21. 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 (Adult Clinical/Academic)

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Contact

SPECTRUM
6507236576

View on ClinicalTrials.gov