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Clinical Trials/NCT02546947
NCT02546947
Completed
Not Applicable

Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery

Centre Chirurgical Marie Lannelongue1 site in 1 country82 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Centre Chirurgical Marie Lannelongue
Enrollment
82
Locations
1
Primary Endpoint
cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ARDS with a PaO2 / FiO2 \< 200 with a PEEP \> 5 since less than 48 hrs
  • Informed consent

Exclusion Criteria

  • NMBA allergy
  • Continuous administration of NMBA for ARDS prior inclusion
  • Age \< 18 yrs

Outcomes

Primary Outcomes

cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)

Time Frame: 2 years

was the primary outcome, calculated by the following formula:(Initial bolus dose +(standard bolus dose x number of repetition doses)+cumulative continuous infusion dose (mg/h x number of hours))/ weight (kg) x duration of administration (hour).

Study Sites (1)

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