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Clinical Trials/NCT01573715
NCT01573715
Unknown
Phase 4

Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS

Assistance Publique Hopitaux De Marseille1 site in 1 country40 target enrollmentApril 2012

Overview

Phase
Phase 4
Intervention
NIMBEX
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
40
Locations
1
Primary Endpoint
Delta TPP
Last Updated
11 years ago

Overview

Brief Summary

Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:

  • reduction of the consumption of oxygen linked to ventilatory workload;
  • increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
  • anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation,
  • reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.

The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Early (\< 48H) Severe ARDS: PaO2 / FiO2 ratio \< 150 with PEEP \>= 5 cmH20

Exclusion Criteria

  • Age \< 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube

Arms & Interventions

severe ARDS patients

Intervention: NIMBEX

control group

Intervention: NIMBEX

control group

Intervention: WITHOUT NIMBEX

moderate SDRA patients

Intervention: NIMBEX

moderate SDRA patients

Intervention: WITHOUT NIMBEX

Outcomes

Primary Outcomes

Delta TPP

Time Frame: 27 months

Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients

Study Sites (1)

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