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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Train of four monitoring
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Chirurgical Marie Lannelongue

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Appropriate clinical group

TOF adapted group

Arm Description

group of patients with clinical dose adjustment

group with an objective of less than 2 responses to TOF stimulation monitored

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2015
Last Updated
February 24, 2017
Sponsor
Centre Chirurgical Marie Lannelongue
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1. Study Identification

Unique Protocol Identification Number
NCT02546947
Brief Title
Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery
Acronym
CURAREA
Official Title
Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appropriate clinical group
Arm Type
No Intervention
Arm Description
group of patients with clinical dose adjustment
Arm Title
TOF adapted group
Arm Type
Active Comparator
Arm Description
group with an objective of less than 2 responses to TOF stimulation monitored
Intervention Type
Other
Intervention Name(s)
Train of four monitoring
Intervention Description
with an end point of one or two response at orbicularis oculi to TOF stimulation
Primary Outcome Measure Information:
Title
cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33002927
Citation
Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stephan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.
Results Reference
derived

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

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