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

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ClinicalTrials.gov Identifier: NCT02546947
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Train of four monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
No Intervention: Appropriate clinical group
group of patients with clinical dose adjustment
Active Comparator: TOF adapted group
group with an objective of less than 2 responses to TOF stimulation monitored
Other: Train of four monitoring
with an end point of one or two response at orbicularis oculi to TOF stimulation




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546947


Locations
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France
Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT02546947    
Other Study ID Numbers: 2013-A00067-38
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Chirurgical Marie Lannelongue:
Respiratory Distress Syndrome, Adult
Neuromuscular Blocking Agents
Atracurium
Mechanical ventilation
ARDS
partial pressure of oxygen(PaO2) /inspired oxygen (FiO2) < 200
Positive End Expiratory Pressure (PEEP) > 5 since less than 48 hrs
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury