New drug combo could save lives in severe shock
NCT ID NCT07063680
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- 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 years and older
- 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.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU Dijon Bourgogne
RECRUITINGDijon, 21000, France