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

NCT ID: NCT01573715

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

severe ARDS patients

Group Type: ACTIVE_COMPARATOR

NIMBEX

Intervention Type: DRUG

control group

Group Type: ACTIVE_COMPARATOR

NIMBEX

Intervention Type: DRUG

WITHOUT NIMBEX

Intervention Type: OTHER

moderate SDRA patients

Group Type: EXPERIMENTAL

NIMBEX

Intervention Type: DRUG

WITHOUT NIMBEX

Intervention Type: OTHER

Interventions

NIMBEX

Intervention Type: DRUG

NIMBEX

Intervention Type: DRUG

WITHOUT NIMBEX

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

magali BISBAL

Role: CONTACT

magali.bisbal@ap-hm.fr

Facility Contacts

magali BISBAL

Role: primary

magali.bisbal@ap-hm.fr

Other Identifiers

2011-39

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005720-18

Identifier Type: -

Identifier Source: org_study_id