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Can calming the nervous system save lives in septic shock?

NCT ID NCT07569536

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether a sedative called dexmedetomidine can improve survival in people with refractory septic shock, a life-threatening condition where blood pressure stays dangerously low despite standard treatments. The drug aims to calm an overactive stress response that makes blood vessels less responsive to pressure-raising medications. About 360 adults will be randomly assigned to receive either dexmedetomidine plus usual care or usual care alone, and researchers will track who is alive after 30 days.

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

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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 : oProven or suspected infection, with modification of the SOFA score ≥ 2 points oWith persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg * And serum lactate level \> 2 mmol/L despite adequate vascular filling \- Catecholamine resistance, defined by * The need for a dose of norepinephrine ≥ 0.5 µg/kg/min for more than 2 consecutive hours * AND persistence of circulatory failure with at least one of the following criteria present in the 2 hours prior to randomization : hyperlactatemia (\> 2 mmol/L) and/or mottling (score ≥ 1) and/or oliguria (diuresis \< 0.5 mL/kg/h over the last 2 hours) * Adequate vascular filling : ≥ 30 mL/kg OR absence of preload-dependency criteria at time of assessment (passive leg lift, pulsed pressure variation) * Invasive mechanical ventilation * Patient affiliated to the national heatlh insurance system * Written consent from the Exclusion Criteria: * Cardiac index \< 2.2 L/min/m2 after volume correction * Bradycardia \< 55 bpm (apart from treatment with ẞ-bloquant) or 2nd or 3rd degree BAV not equipped * Patients who are moribund or for whom death appears imminent within 24 hours (as determined by the investigator's clinical judgment * Severe hepatic insufficiency with TP and factor \< 50% in the absence of DIC (disseminated intravascular coagulationà * Hypersensitivity to dexmedetomidine * Patient on dexmedetomidine before inclusion * Patients who received iproniazide within the 15 days preceding randomization * Patient for whom a decision has been made to limit the use of therapies * Person subject to limited judicial protection or a legal protection measure (curatorship, guardianship) * Patients participating in another clinical study with an ongoing exclusion period at the time of inclusion * Pregant or breastfeeding woman

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome Vasoplegia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock, vasopressor resistance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP - Hôpital Raymond-Poincaré - Service de Médecine intensive-réanimation

    Garches, 92380, France

  • CHU Amiens-Picardie - Service de médecine intensive-réanimation

    Amiens, 80054, France

  • CHU Dijon Bourgogne - Service de médecine intensive et réanimation

    Dijon, 21000, France

  • CHU de Rennes - Service de médecine intensive et réanimation

    Rennes, 35033, France

  • Centre Hospitalier Chalon-sur-Saône - Service de réanimation et surveillance continue

    Chalon-sur-Saône, 71321, France

  • Centre Hospitalier Départemental de Vendée - Service de réanimation polyvalente

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Intercommunal de Toulon - Service de réanimation polyvalente

    Toulon, 83100, France

  • Centre Hospitalier Le Mans - Service de réanimation médico-chirurgicale

    Le Mans, 72037, France

  • Centre Hospitalier de Dieppe - Service de réanimation et unité de soins continus

    Dieppe, 76202, France

  • HOPITAL NORD FRANCHE-COMTE - Service de réanimation

    Trévenans, 90400, France

  • Hôpital Edouard Herriot - Service de Médecine intensive - reanimation

    Lyon, 69003, France

  • Hôpital Nord - CHU Saint Etienne - Service de médecine intensive

    Saint-Priest-en-Jarez, 42270, France

  • Hôpital Saint Joseph Saint Luc - Service de réanimation

    Lyon, 69007, France

  • Hôpital de l'archet - Service de médecine intensive et réanimation

    Nice, 06200, France

  • Hôpital de la Croix Rousse - Service de médecine intensive et réanimation

    Lyon, 69004, France

  • Médipôle Hôpital Privé Lyon Villeurbanne- Service de réanimation polyvalente

    Villeurbanne, 69100, France

  • Nouvel Hôpital Civil - Service de médecine intensive et réanimation

    Strasbourg, 67091, France

  • Service d'Anesthésie - Médecine Intensive - Réanimation Hôpital Lyon Sud

    Pierre-Bénite, 69310, France

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