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Efficacy of early Argipressin (arginine vasopressin) in the management of intensive care patients with norepinephrine-refractory vasoplegic shock: a multicentric randomized, double-blind placebo-controlled superiority trial : Vaso²R
EU CTIS ID: 2024-516639-28-00
What this study is testing
To evaluate the efficacy (reduction of mortality, reduction of renal replacement therapy duration, reduction of vasopressor administration) of early Argipressin treatment (arginine vasopressin, REVERPLEG®) compared to placebo in adult patients with refractory vasoplegic shock
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged ≥ 18 years
- Vasoplegic shock: patient requiring vasopressor AND with a cardiac index ≥ 2.3/L/min/m² (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) AND with hyperlactatemia > 2 mmol/l.
- 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
- 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
You likely can't join if
- Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)
- Patient already enrolled in an interventional trial
- Decision to limit life-sustaining treatments
- under legal protection
- Pregnant, parturient or breastfeeding women
- Ongoing vasopressin treatment
See the full eligibility criteria
- Patients aged ≥ 18 years
- Vasoplegic shock: patient requiring vasopressor AND with a cardiac index ≥ 2.3/L/min/m² (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) AND with hyperlactatemia > 2 mmol/l.
- 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
- 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
- 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
- Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)
- Patient already enrolled in an interventional trial
- Decision to limit life-sustaining treatments
- under legal protection
- Pregnant, parturient or breastfeeding women
- 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®
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.