Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
NIMBEX
NIMBEX
WITHOUT NIMBEX
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility 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
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
severe ARDS patients
control group
moderate SDRA patients
Arm Description
Outcomes
Primary Outcome Measures
Delta TPP
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
Secondary Outcome Measures
Full Information
NCT ID
NCT01573715
First Posted
April 5, 2012
Last Updated
August 29, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01573715
Brief Title
Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)
Official Title
Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
severe ARDS patients
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Active Comparator
Arm Title
moderate SDRA patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NIMBEX
Intervention Type
Drug
Intervention Name(s)
NIMBEX
Intervention Type
Other
Intervention Name(s)
WITHOUT NIMBEX
Primary Outcome Measure Information:
Title
Delta TPP
Description
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
Time Frame
27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
magali BISBAL
Email
magali.bisbal@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magali BISBAL
Email
magali.bisbal@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
magali BISBAL
12. IPD Sharing Statement
Learn more about this trial
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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