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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: April 5, 2012
Last updated: August 29, 2014
Last verified: August 2014

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.

Condition Intervention Phase
Acute Respiratory Distress Syndrome Drug: NIMBEX Other: WITHOUT NIMBEX Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS

Resource links provided by NLM:

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: severe ARDS patients Drug: NIMBEX
Active Comparator: control group Drug: NIMBEX Other: WITHOUT NIMBEX
Experimental: moderate SDRA patients Drug: NIMBEX Other: WITHOUT NIMBEX


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01573715

Contact: magali BISBAL

Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: magali BISBAL   
Principal Investigator: magali BISBAL         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01573715     History of Changes
Other Study ID Numbers: 2011-005720-18
2011-39 ( Other Identifier: AP HM )
Study First Received: April 5, 2012
Last Updated: August 29, 2014

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on September 19, 2017