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New drug combo could save lives in severe shock

NCT ID NCT07063680

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a drug called argipressin early, along with standard treatment, can help ICU patients with a severe type of shock that doesn't respond to usual medications. About 390 adults will be randomly assigned to receive either argipressin or a placebo. The goal is to see if this approach improves survival, reduces the need for kidney dialysis, and shortens the time patients need blood pressure support.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Argipressin (a synthetic form of the hormone vasopressin)
What this could lead to
If it works, this could provide a better treatment for a life-threatening type of shock that doesn't respond to standard drugs, potentially saving more lives and reducing kidney failure.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. The benefit may be small or not exist, and argipressin can cause side effects like reduced blood flow to the gut or fingers.

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 390 people

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

Started

Apr 2026

Expected to finish

Jan 2029

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: * Patients aged ≥ 18 years * Vasoplegic shock defined as patient requiring vasopressor at the time of inclusion AND with a cardiac index ≥ 2.3/L/min/m² \[32\] (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) and with hyperlactatemia \> 2 mmol/l. * Vasoplegia must be primarily caused by one of the following etiologies: * Sepsis (documented or clinically suspected infection) * Post-operative vasoplegia (following cardiac or non-cardiac surgery) * Post hemorrhage * Sterile systemic inflammation (e.g., pancreatitis, burns, trauma) * Anaphylaxis * Liver failure * Other causes of vasoplegia * Refractory shock: dose of vasopressor (express as norepinephrine base equivalent) ≥ 0.25 μg/kg/min in order to maintain perfusion pressure within patient-defined targets (defined by the physician in charge of the patient). * Early intervention: Criteria for refractory AND vasoplegic shock reached for less than 12 hours. * Informed consent obtained from the patient or, if unable to give consent, a surrogate. If the surrogate is not available, emergency consent can be considered. * Covered by French national health insurance Exclusion Criteria: * Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition) * Ongoing vasopressin treatment * Ongoing inotrope treatment (except norepinephrine) * Ongoing acute coronary syndrome, mesenteric ischemia * Uncontrolled active bleeding * Vasoplegia due to neurogenic shock * Vasospastic disease (Raynaud's disease, systemic scleroderma…) * Hyponatremia \<120 mmol l-1 * Known hypersensitivity to Argipressin or to any of the excipients of REVERPLEG®. * Patient already enrolled in an interventional trial * Decision to limit life-sustaining treatments * Person under legal protection * Pregnant, parturient or breastfeeding women

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As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • CHU Dijon Bourgogne

    RECRUITING

    Dijon, 21000, France