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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Unknown; Phase 4

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: NIMBEX; Other: WITHOUT NIMBEX

Study type: Interventional

Funder types: Other

Identifiers

NCT01573715

2011-005720-18

2011-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

severe ARDS patients

Active Comparator group

Treatment:

Drug: NIMBEX

Drug: NIMBEX

control group

Active Comparator group

Treatment:

Other: WITHOUT NIMBEX

Drug: NIMBEX

Drug: NIMBEX

moderate SDRA patients

Experimental group

Treatment:

Other: WITHOUT NIMBEX

Drug: NIMBEX

Drug: NIMBEX