Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medicine called vasopressin early on can help patients who are very sick with a type of shock called vasoplegic shock that doesn’t get better with the usual treatment, norepinephrine. Vasoplegic shock happens when the blood vessels relax too much, causing low blood pressure and poor blood flow to organs, even though the heart is still pumping well. This can happen after severe infections, surgeries, or other serious conditions. The researchers want to see if using vasopressin along with norepinephrine can improve survival, help kidney function, and reduce the time patients need medicines to support their blood pressure.

Adults 18 years and older who are in intensive care with this kind of shock that is not responding well to norepinephrine might be eligible. To join, patients need to have signs of vasoplegic shock for less than 12 hours, with certain measurements showing the heart is pumping enough but the blood pressure is still low despite strong doses of norepinephrine. Patients with other serious conditions like ongoing heart attacks, active bleeding, or those already on vasopressin won’t be able to participate. If you or a loved one qualifies and agrees to take part, the medical team will carefully monitor the effects of adding vasopressin to see if it helps improve outcomes compared to standard treatment with norepinephrine alone. This study aims to provide clearer answers about the best way to treat this serious condition.

Gender

ALL

Eligibility criteria

• 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