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The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:
Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive strategy | Experimental | Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements |
|
| Control strategy | Other | Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive strategy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality by 28 days after randomisation | Patients will be followed from randomization to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| To account for the potential bias brought by deaths occurring as the result of life-sustaining treatments withdrawal/withholding, as frequently encountered in intensive care unit, the investigators will record such events | From inclusion to Day 35 | |
| Cumulative incidence of death |
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Inclusion Criteria:
Age ≥ 18 years the day of inclusion
Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grégoire MULLER | University of New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care | Argenteuil | France | ||||
| Intensive care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159885 | Result | 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. | |
| 34521655 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2018 | Apr 25, 2025 |
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|
| Control strategy | Procedure | 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. |
|
| From inclusion through Day 90 |
| Cumulative survival free of indwelling arterial catheter insertion | From inclusion through Day 90 |
| Number of patients who underwent indwelling arterial catheter insertion, in both groups | From randomization to Day 28 |
| Evolution of daily Sequential Organ Failure Assessment (SOFA) score | The score (ranged from 0 to 24, the worth outcome) is based on six sub-scores (each ranged from 0 to 4, the worth outcome), one for each respiratory system, neurological, cardiovascular, hepatic, renal and coagulation. | During the first seven days |
| Daily amount of intravenous fluid given for rapid vascular volume expansion | From Day 1 to Day 7 |
| Duration of mechanical ventilation | From inclusion to Day 28 |
| Ventilator-free days | Patients dying between randomisation and Day 28 will be assigned a 0 value; for survivors at Day 28, all the days free of invasive mechanical ventilation through an endotracheal tube within the 28-day period will be taken into account | From Day 1 to Day 28 |
| Proportion of patients treated by renal-replacement therapy | Between Day 1 and Day 28 |
| Renal replacement therapy-free days | Days without renal replacement therapy from Day 1 to Day 28 for survivors at Day 28, and from Day 1 to the date of death for patients dying before Day 28, will be taken into account | From Day 1 to Day 28 |
| Proportion of patients treated by vasopressor | Between Day 1 and Day 28 |
| Vasopressor therapy-free days | Days without vasopressor therapy from Day 1 to Day 28 for survivors at Day 28, and from Day 1 to the date of death for patients dying before Day 28, will be taken into account | From Day 1 to Day 28 |
| Mean daily blood volume drawn for lab testing during intensive care unit stay | From inclusion to Day 28 |
| Number of blood cultures performed during intensive care unit stay | From inclusion to Day 28 |
| Number of attempts at arterial puncture during intensive care unit stay | From inclusion to Day 28 |
| Evolution of blood haemoglobin level | From Day 1 to Day 28 |
| Evolution of haematocrit | From Day 1 to Day 28 |
| Number of red blood cell packs transfused | From Day 1 to Day 28 |
| Number of transcutaneous arterial and venous puncture for lab tests, arterial catheter insertion and set up of monitor, blood drawing from the arterial catheter or other vascular line | From inclusion to Day 28 |
| Time (min) spent by nurses and physicians (min) on these tasks | This outcome measure is planned to be collected during the first three days in a random sample of 10% of the study population and will be only considered during the medico-economic analyses. | During the first three days of the intensive care unit stay |
| Number of arterial and central venous catheter insertion during intensive care unit stay | Expressed as the incidence of new cases per 1000 catheter-days, including local and catheter-related bloodstream infections as consensually defined. | From inclusion to Day 28 |
| Numbers of arterial and central venous catheter-related infections | Number of new cases per 1000 catheter-days | During intensive care unit stay |
| Numbers of local infections of arterial and central venous | Number of new cases per 1000 catheter-days | During intensive care unit stay |
| Numbers of arterial and central venous catheter-related bloodstream infections | Number of new cases per 1000 catheter-days | During intensive care unit stay |
| Number of bloodstream infections | During intensive care unit stay |
| Duration of intensive care unit stay | From inclusion to discharge |
| Duration of hospital stay | From inclusion to discharge |
| Intensive care unit mortality | From inclusion to discharge |
| Hospital mortality | From inclusion to discharge |
| Day 90 mortality | Day 90 |
| Number of Adverse Events of special interest | From inclusion to Day 90 |
| Incremental Cost-Effectiveness Ratio | At Day 28 |
| Budget impact analysis of the generalization of the non-invasive strategy | The budget impact analysis will be to multiply the average annual cost per patient over 5 years by the number of eligible patients, taking into account a penetration rate | on a 5 years' time frame |
| Pain related to the device used for blood pressure monitoring | Numerical scale assessment of patient-reported pain related to the device used for blood pressure monitoring. Using the following 11-point numerical scales, ranged from 0 (no pain) to 10 (very important and permanent pain). | Once a day, from inclusion to Day 28 |
| Discomfort related to device used for blood pressure monitoring | Numerical scale assessment of patient-reported discomfort related to the device used for blood pressure monitoring Using the following 11-point numerical scales, ranged from 0 (no discomfort) to 10 (very important and permanent discomfort). | One a day, from inclusion to Day 28 |
| Daily fluid balance of intakes and loss | Difference between the daily amounts of:
| The first seven days |
| 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 |
| Derived |
| 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. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2024 | Apr 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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