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Could a common sedative save lives in septic shock?

NCT ID NCT03953677

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a sedative drug called dexmedetomidine could help restore blood pressure control in patients with severe septic shock that does not respond to standard treatments. The trial involved 32 adults in intensive care. The goal was to see if the drug could improve the body's response to a blood-pressure-raising medication, potentially reducing the risk of death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

32 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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 old * Septic shock, defined by the "Sepsis-3" criteria * proven or suspected infection, with modification of the SOFA score ≥ 2 points, * with persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg * and a serum lactate level \> 2 mmol/L despite adequate vascular filling * Adequate vascular filling: ≥ 30ml/kg, OR absence of preload-dependency criteria at time of assessment (respiratory variability of the inferior vena cava, passive leg lift, pulsed pressure variation) * Catecholamine resistance, defined by the need for a dose of norepinephrine ≥ 0,5 µg/kg/min for more than 2 consecutive hours within 24 hours of admission to intensive care unit * persistence of circulatory failure with at least one of the following criteria present in the 2 hours prior to randomisation: hyperlactatemia \> 2mmol/l, and/or mottling (≥ 1 score), and/or oliguria (diuresis \< 0,5 ml/kg/h over the last 2 hours) * Invasive Mechanical ventilation * Under sedation by midazolam or propofol * Informed consent obtained from a relative for patient included in an emergency * Patient affiliated to the national health insurance system Exclusion Criteria: * Cardiac arrest before inclusion and occurring before septic shock criteria are met * Cardiac index \< 2.2 l/min/m² after volume correction, or left ventricular ejection fraction \< 40% on echocardiography * Bradycardia \< 55 bpm (apart from treatment with β-blocker) or 2nd or 3rd degree BAV not equipped * Proven or suspected decompensation of coronary heart disease * Acute cerebrovascular condition within 2 weeks prior to inclusion * Severe hepatic insufficiency with TP and factor V \<50% in the absence of DIC (disseminated intravascular coagulation) * Patient on adrenaline or vasopressors at the time of inclusion (epinephrine or vasopressin stopped prior to inclusion is not a criterion for non-inclusion) * Patient on non-selective MAOI iproniazid within 15 days of inclusion * Patient for whom a decision has been made to limit the use of therapies * Hypersensitivity to dexmedetomidine or phenylephrine * Patient on dexmedetomidine before inclusion * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to limited judicial protection * Pregnant, parturient or breastfeeding woman * Patient with suspected or confirmed mesenteric ischemia

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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

  • Chu Dijon Bourgogne

    Dijon, 21000, France

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Other studies related to the condition(s) this trial covers.