ICU shock study: delaying arterial catheters may be just as safe
NCT ID NCT03680963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether waiting to place an arterial catheter (a thin tube in an artery to monitor blood pressure) in critically ill patients with shock is as safe as placing it right away. Over 1,000 adults in intensive care were randomly assigned to either early or delayed catheter insertion. The main goal was to see if delaying the procedure affected the number of deaths within 28 days. The findings help doctors decide the best timing for this common ICU procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,010 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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Feb 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Intensive care
Argenteuil, France
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Intensive care
Dijon, France
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Intensive care
La Roche-sur-Yon, France
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Intensive care
Montauban, France
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Intensive care
Nantes, France
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Intensive care
Orléans, France
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Intensive care
Poitiers, France
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Intensive care
Strasbourg, France
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Intensive care
Tours, France
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Other studies related to the condition(s) this trial covers.
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