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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)

This study is currently recruiting participants.
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01573715
First received: April 5, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Delta TPP [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    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: June 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

Contacts
Contact: magali BISBAL magali.bisbal@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: magali BISBAL         magali.bisbal@ap-hm.fr    
Principal Investigator: magali BISBAL            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01573715     History of Changes
Other Study ID Numbers: 2011-005720-18, 2011-39
Study First Received: April 5, 2012
Last Updated: September 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
 Lung Injury
Neuromuscular Blocking Agents
Cisatracurium
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013