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

RecruitingPhase 3Ages 18 Years - anyAllCentre Hospitalier Universitaire Dijon
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In plain words

What the trial is, and whether it could suit you

Acute circulatory failure (shock) is defined as insufficient oxygen transport to meet the oxygen requirements of organs and tissues. Vasoplegic shock is the most frequent cause of shock, defined by vasoplegia and a drop in arterial pressure with preserved cardiac output. The main aetiologies of vasoplegic shock are sepsis and post-operative vasoplegia. Symptomatic treatment of vasoplegic shock is based on vasopressors. The first-line vasopressor is norepinephrine. Refractory vasoplegic shock refers as high norepinephrine requirements. In patients with catecholamine-refractory vasoplegia, the use of vasopressin as a second-line treatment is proposed. The use of vasopressin could improve organ and tissue perfusion, improve renal function, accelerate shock reversal and reduce patients' exposure to catecholamines, and thus to their side effects. Currently, there is a gap between evidence an

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📋 Eligibility rules (as published)
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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What it tests

  • Argipressin
  • Chlorure de sodium
  • Collection of clinical data
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Where

1 site
CHU Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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