Acute Respiratory Distress SyndromeCURAREANCT02546947
Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery
A study testing Train of four monitoring in people with Acute Respiratory Distress Syndrome, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Train of four monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS with a PaO2 / FiO2 < 200 with a PEEP > 5 since less than 48 hrs
- Informed consent
Who cannot join
- NMBA allergy
- Continuous administration of NMBA for ARDS prior inclusion
- Age < 18 yrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Train of four monitoring
- 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
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four monitoringOther
with an end point of one or two response at orbicularis oculi to TOF stimulation
| Study group | Role | What they receive |
|---|---|---|
| Appropriate clinical group | No intervention | group of patients with clinical dose adjustment |
| TOF adapted group | Active comparator | group with an objective of less than 2 responses to TOF stimulation monitored Receives: Other: Train of four monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546947
- Sponsor's protocol ID
- 2013-A00067-38
- Acronym
- CURAREA
- Status last verified
- Feb 2017
- First submitted
- 27 Aug 2015
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33002927
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT02546947
- Acronym / sponsor ID
- CURAREA / 2013-A00067-38
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appropriate clinical group | No intervention | –group of patients with clinical dose adjustment |
| TOF adapted group | Active comparator | Other: Train of four monitoringgroup with an objective of less than 2 responses to TOF stimulation monitored |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ARDS with a PaO2 / FiO2 < 200 with a PEEP > 5 since less than 48 hrs
- Informed consent
Key exclusion criteria (3 listed)
- NMBA allergy
- Continuous administration of NMBA for ARDS prior inclusion
- Age < 18 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Train of four monitoringwith an end point of one or two response at orbicularis oculi to TOF stimulation | Other | TOF adapted group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Derived from this study: PubMed 33002927Rezaiguia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Train of four monitoring in people with Acute Respiratory Distress Syndrome, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.