Reevaluation Of Systemic Early Neuromuscular Blockade



Status:Active, not recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:January 4, 2016
End Date:April 4, 2019

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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 .

PRIMARY OBJECTIVE::

To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and
morbidity in patients with moderate-severe ARDS, in comparison to a control group with no
routine early neuromuscular blockade (NMB).

PRIMARY HYPOTHESIS:

Early neuromuscular blockade will improve mortality prior to discharge home before day 90, in
patients with moderate-severe ARDS.

The trial will accrue a maximum of 1408 patients. Patients will be recruited from the
emergency departments, intensive care units and other acute care areas of the PETAL Network
Clinical Centers and randomized to the active (NMB) or control. The overall strategy is to
screen, consent, and enroll early, every newly intubated, acutely ill or post-operative,
eligible patient at each site, using clinically obtained pulse oximetry and blood gases.

By preventing active expiration, and/or patient ventilator dyssynchrony, neuromuscular
blockade may create a more homogenous distribution of airway pressures and tidal volumes,
preventing barotrauma/volutrauma and "atelectrauma" resulting in less ventilator-induced lung
injury.

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)
We found this trial at
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Boston, Massachusetts 02115
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330 Brookline Ave
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2500 N State St
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