Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)

August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille

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

Unknown

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:
        • Principal Investigator:
          • magali BISBAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

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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