Reevaluation Of Systemic Early Neuromuscular Blockade

Not Recruiting

Trial ID: NCT02509078

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

Stanford Investigator(s)

Joseph Levitt, MD, MS
Joseph Levitt, MD, MS

Associate Professor of Medicine (Pulmonary and Critical Care Medicine)

Matthew Strehlow
Matthew Strehlow

Professor of Emergency Medicine (Adult Clinical/Academic)

Eligibility


Inclusion Criteria

   1. Age > 18 years

   2. 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.

Exclusion Criteria:

   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)

Intervention(s):

drug: Cisatracurium Besylate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SPECTRUM
6507236576