Study of Higher breathing machine pressure settings with/without muscle relaxant for Acute Respiratory Distress Syndrome (ARDS)

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"Does early treatment with muscle relaxant improve recovery from lung injury?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
acute respiratory distress syndrome, muscle relaxant
Type:
Drug study, Phase 3
Investigator:
Description
This study evaluates if early treatment with a skeletal muscle relaxant can increase the chance of survival. Skeletal muscle relaxant medicine temporarily prevents all muscle movement (a temporary form of paralysis) to allow rest and better breathing on the breathing machine. Some studies have shown early treatment with muscle relaxant may improve recovery from your type of lung injury. But doctors don’t know for sure which is better – always giving early muscle relaxant or only when thought necessary; both methods are used by doctors. 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
This study requires
Blood tests
Urine tests
Medical record review
Muscle Relaxer/Discouraged muscle relaxer
Higher lung pressure settings on the mechanical ventilator to keep their lungs open and get more oxygen when on the breathing machine
Who can participate?
Inclusion Criteria

1. Age > 18 years

2. Presence of all of the following conditions for < 48 hours:

i. PaO2/FiO2 /= 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:

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)
Resources
Schedule
Study duration and period
Variable during hospitalization Follow up call: Three months, Six months, Twelve months
Recruitment period
From Jan. 11, 2016
Location
UC Davis Department of Internal Medicine
4150 V Street
Suite 3400
Sacramento, CA 95817
Research Topic
Conditions:
  • Acute Respiratory Distress Syndrome

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