Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure:
NCT ID: NCT03680963
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1010 participants
INTERVENTIONAL
2018-11-15
2023-02-28
Brief Summary
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1. a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
2. a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.
Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Non-invasive strategy
Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements
Non-invasive strategy
No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.
In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure).
Control strategy
Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure
Control strategy
An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.
Interventions
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Non-invasive strategy
No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.
In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure).
Control strategy
An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.
Eligibility Criteria
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Inclusion Criteria
* Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
1. Persisting hypotension (systolic blood pressure less than 90 mmHg or mean arterial blood pressure less than 65 mmHg) for more than 15 min at intensive care unit admission or within the following 24 hours, OR requirement of continuous intravenous vasopressor treatment (i.e. any dose of norepinephrine / epinephrine)
2. Presence at least one of the following signs of hypoperfusion: alteration of mental status; skin mottling; oliguria defined as a urine output \< 0.5 mL/kg body weight for at least one hour; arterial lactate \> 2 mmol/L; peripheral venous lactate \> 3.2 mmol/L; ScvO2 \<70%
* Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available
* French health insurance holder
* Non invasive blood pressure (NIBP) device fails to display a blood pressure value, or cuff placement impossible
* Patient for whom an Extra-Corporeal Membrane Oxygenation (ECMO) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours
* Patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 mL at the rate of 66 mL/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base)
* Severe traumatic brain injury (i.e., traumatic brain injury with a Glasgow coma scale score of less than 9 before sedation)
* Patient previously included in the trial
* Body mass index (BMI) above 40 kg/m2
* Pregnancy
* Brain death
* Moribund patient
* Patient known, at time of inclusion, as being under guardianship, authorship or curators
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Grégoire MULLER
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY HOSPITAL, ORLEANS
Locations
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Intensive care
Argenteuil, , France
Intensive care
Dijon, , France
Intensive care
La Roche-sur-Yon, , France
Intensive care
Montauban, , France
Intensive care
Nantes, , France
Intensive care
Orléans, , France
Intensive care
Poitiers, , France
Intensive care
Strasbourg, , France
Intensive care
Tours, , France
Countries
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References
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Muller G, Contou D, Ehrmann S, Martin M, Andreu P, Kamel T, Boissier F, Azais MA, Monnier A, Vimeux S, Chenal A, Nay MA, Salmon Gandonniere C, Lascarrou JB, Roudaut JB, Plantefeve G, Giraudeau B, Lakhal K, Tavernier E, Boulain T; CRICS-TRIGGERSEP F-CRIN Network and the EVERDAC Trial Group. Deferring Arterial Catheterization in Critically Ill Patients with Shock. N Engl J Med. 2025 Nov 13;393(19):1875-1888. doi: 10.1056/NEJMoa2502136. Epub 2025 Oct 29.
Muller G, Kamel T, Contou D, Ehrmann S, Martin M, Quenot JP, Lacherade JC, Boissier F, Monnier A, Vimeux S, Brunet Houdard S, Tavernier E, Boulain T. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol. BMJ Open. 2021 Sep 14;11(9):e044719. doi: 10.1136/bmjopen-2020-044719.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DR180137
Identifier Type: -
Identifier Source: org_study_id