Skip to main content
OpenTrials
Completed

NCT Number: NCT03680963

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

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. 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive care, Argenteuil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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%
  • 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

  • Acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours
  • 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

Treatment and study plan

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).

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.

Primary outcomes

  1. All-cause mortality by 28 days after randomisation

    Time frame: Patients will be followed from randomization to day 28

Secondary outcomes

  1. 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

    Time frame: From inclusion to Day 35

  2. Cumulative incidence of death

    Time frame: From inclusion through Day 90

  3. Cumulative survival free of indwelling arterial catheter insertion

    Time frame: From inclusion through Day 90

  4. Number of patients who underwent indwelling arterial catheter insertion, in both groups

    Time frame: From randomization to Day 28

  5. Evolution of daily Sequential Organ Failure Assessment (SOFA) score

    Time frame: During the first seven days

    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.

  6. Daily amount of intravenous fluid given for rapid vascular volume expansion

    Time frame: From Day 1 to Day 7

  7. Duration of mechanical ventilation

    Time frame: From inclusion to Day 28

  8. Ventilator-free days

    Time frame: From Day 1 to Day 28

    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

  9. Proportion of patients treated by renal-replacement therapy

    Time frame: Between Day 1 and Day 28

  10. Renal replacement therapy-free days

    Time frame: From Day 1 to Day 28

    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

  11. Proportion of patients treated by vasopressor

    Time frame: Between Day 1 and Day 28

  12. Vasopressor therapy-free days

    Time frame: From Day 1 to Day 28

    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

  13. Mean daily blood volume drawn for lab testing during intensive care unit stay

    Time frame: From inclusion to Day 28

  14. Number of blood cultures performed during intensive care unit stay

    Time frame: From inclusion to Day 28

  15. Number of attempts at arterial puncture during intensive care unit stay

    Time frame: From inclusion to Day 28

  16. Evolution of blood haemoglobin level

    Time frame: From Day 1 to Day 28

  17. Evolution of haematocrit

    Time frame: From Day 1 to Day 28

  18. Number of red blood cell packs transfused

    Time frame: From Day 1 to Day 28

  19. 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

    Time frame: From inclusion to Day 28

  20. Time (min) spent by nurses and physicians (min) on these tasks

    Time frame: During the first three days of the intensive care unit stay

    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.

  21. Number of arterial and central venous catheter insertion during intensive care unit stay

    Time frame: From inclusion to Day 28

    Expressed as the incidence of new cases per 1000 catheter-days, including local and catheter-related bloodstream infections as consensually defined.

  22. Numbers of arterial and central venous catheter-related infections

    Time frame: During intensive care unit stay

    Number of new cases per 1000 catheter-days

  23. Numbers of local infections of arterial and central venous

    Time frame: During intensive care unit stay

    Number of new cases per 1000 catheter-days

  24. Numbers of arterial and central venous catheter-related bloodstream infections

    Time frame: During intensive care unit stay

    Number of new cases per 1000 catheter-days

  25. Number of bloodstream infections

    Time frame: During intensive care unit stay

  26. Duration of intensive care unit stay

    Time frame: From inclusion to discharge

  27. Duration of hospital stay

    Time frame: From inclusion to discharge

  28. Intensive care unit mortality

    Time frame: From inclusion to discharge

  29. Hospital mortality

    Time frame: From inclusion to discharge

  30. Day 90 mortality

    Time frame: Day 90

  31. Number of Adverse Events of special interest

    Time frame: From inclusion to Day 90

  32. Incremental Cost-Effectiveness Ratio

    Time frame: At Day 28

  33. Budget impact analysis of the generalization of the non-invasive strategy

    Time frame: on a 5 years' time frame

    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

  34. Pain related to the device used for blood pressure monitoring

    Time frame: Once a day, from inclusion to Day 28

    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).

  35. Discomfort related to device used for blood pressure monitoring

    Time frame: One a day, from inclusion to Day 28

    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).

  36. Daily fluid balance of intakes and loss

    Time frame: The first seven days

    Difference between the daily amounts of:

    • daily fluid administration (in milliliter): intravenous hydration, vascular filling, enteral hydration
    • and the daily fluid loss (in milliliter): urine and fluid removal (during renal replacement therapy), tube drainage, estimated blood loss (laboratory test, bleeding)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)

Acronym: EVERDAC

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 21, 2018
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.