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
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 1, 2014
August 1, 2014
2.4 years
April 5, 2012
August 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Delta TPP
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
27 months
Study Arms (3)
severe ARDS patients
ACTIVE COMPARATORcontrol group
ACTIVE COMPARATORmoderate SDRA patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Early (\< 48H) Severe ARDS: PaO2 / FiO2 ratio \< 150 with PEEP \>= 5 cmH20
You may not qualify if:
- Age \< 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 9, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
September 1, 2014
Record last verified: 2014-08