Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)

Phase 4

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Drug: NIMBEX; Other: WITHOUT NIMBEX

• Registration Number: NCT01573715
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Primary Completion: 2014-09
• Last Update Posted: 2014-09-01
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate SDRA patients	NIMBEX	-
control group	WITHOUT NIMBEX	-
moderate SDRA patients	WITHOUT NIMBEX	-
severe ARDS patients	NIMBEX	-
control group	NIMBEX	-

Primary Outcome Measures

Name	Time	Method
Delta TPP	27 months	Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France