- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573715
Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)
Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: magali BISBAL
- Email: magali.bisbal@ap-hm.fr
Study Locations
-
-
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Marseille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- magali BISBAL
- Email: magali.bisbal@ap-hm.fr
-
Principal Investigator:
- magali BISBAL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
|
|
Active Comparator: severe ARDS patients
|
|
Experimental: moderate SDRA patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
27 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Neuromuscular Agents
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Cisatracurium
- Atracurium
Other Study ID Numbers
- 2011-005720-18
- 2011-39 (Other Identifier: AP HM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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