Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure:

NCT03680963 | Completed

• 1 other identifier: DR180137
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 9

Brief Summary

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:

1. 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. 2.a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.

Conditions

Acute Circulatory Failure

Outcome Measures

Primary Outcomes (1)

• All-cause mortality by 28 days after randomisation

  Patients will be followed from randomization to day 28

Secondary Outcomes (36)

• 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

  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

  During the first seven days

Study Arms (2)

Non-invasive strategy

EXPERIMENTAL

Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements

Procedure: Non-invasive strategy

Control strategy

OTHER

Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure

Procedure: Control strategy

Interventions

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.

Control strategy

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).

Non-invasive strategy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
• 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)
• 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%
• French health insurance holder

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (9)

Intensive care

Argenteuil, France

Location

Intensive care

Dijon, France

Location

Intensive care

La Roche-sur-Yon, France

Location

Intensive care

Montauban, France

Location

Intensive care

Nantes, France

Location

Intensive care

Orléans, France

Location

Intensive care

Poitiers, France

Location

Intensive care

Strasbourg, France

Location

Intensive care

Tours, France

Location

Related Publications (2)

• 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.

  PMID: 41159885 RESULT

• 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.

  PMID: 34521655 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grégoire MULLER

  UNIVERSITY HOSPITAL, ORLEANS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 21, 2018
• Study Start: November 15, 2018
• Primary Completion: November 29, 2022
• Study Completion: February 28, 2023
• Last Updated: December 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)