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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)

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ClinicalTrials.gov Identifier: NCT01573715
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 9, 2012
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: NIMBEX Other: WITHOUT NIMBEX Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01573715     History of Changes
Other Study ID Numbers: 2011-005720-18
2011-39 ( Other Identifier: AP HM )
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
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