Argipressin (arginine vasopressin) for Vasoplegic shock (norepinephrine-refractory)

Inclusion criteria

• {"criterion_text":"-Patients aged ≥ 18 years\n-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.\n-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\n-Early intervention: Criteria for refractory AND vasoplegic shock reached for less than 12 hours.\n-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.\n-Covered by French national health insurance\n-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"}

Exclusion criteria

• {"criterion_text":"-Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)\n-Patient already enrolled in an interventional trial\n-Decision to limit life-sustaining treatments\n-under legal protection\n-Pregnant, parturient or breastfeeding women\n-Ongoing vasopressin treatment\n-Ongoing inotrope treatment (except norepinephrine)\n-Ongoing acute coronary syndrome, mesenteric ischemia\n-Uncontrolled active bleeding\n-Vasoplegia due to neurogenic shock\n-Vasospastic disease (Raynaud's disease, systemic scleroderma, …)\n-Hyponatremia <120 mmol l-1\n-Known hypersensitivity to Argipressin or to any of the excipients of REVERPLEG®"}

Primary endpoints

• {"endpoint_text":"-Composite score including 3 criterions ordered from most to the least important: -mortality at D30 -use of renal replacement therapy (RRT) within 30 days post-inclusion -persistance of vasopressor use within 15 days post-inclusion. The score is calculated by comparing each patient from one group to all patients from the other group in the concerned strata (stratified win-ratio analysis).","definition_or_measurement_approach":"The score is calculated by comparing each patient from one group to all patients from the other group in the concerned strata (stratified win-ratio analysis)."}

Secondary endpoints

• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 1.number of all cause deaths in ICU, at D30 and D90","definition_or_measurement_approach":"All-cause mortality in ICU measured at day 30 and day 90 post-inclusion."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 2.renal failure (score ≥ 2 on the kidney disease improving global outcome (KDIGO) classification) at D30 and D90","definition_or_measurement_approach":"Renal failure defined as KDIGO score ≥ 2 assessed at day 30 and day 90."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 3.Arrhythmia requiring treatment, myocardial injury within 7 days","definition_or_measurement_approach":"Occurrence of arrhythmia requiring treatment or myocardial injury within 7 days post-inclusion."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 4.Vasoactive Inotropic Score (VIS) between day 0 (D0) and 7 (D7)","definition_or_measurement_approach":"Change or comparison in Vasoactive Inotropic Score (VIS) from day 0 to day 7."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 5.Renal replacement therapy free days, vasopressor free days ventilator free days at D30 and D90","definition_or_measurement_approach":"Number of days free of renal replacement therapy, vasopressors, and mechanical ventilation at day 30 and day 90."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 6.Length of stay (days) in intensive care unit (ICU)","definition_or_measurement_approach":"Duration of ICU stay measured in days."}
• {"endpoint_text":"-Efficacy objectives: comparison between experimental group and placebo group: 7.Length of stay (days) until discharge from hospital","definition_or_measurement_approach":"Duration from inclusion until hospital discharge measured in days."}
• {"endpoint_text":"-Safety objectives: 8.Number of serious adverse events according to the MedDRA classification in both groups","definition_or_measurement_approach":"Number of serious adverse events classified according to MedDRA in each group."}

France

Earliest CTIS Part Ii Submission Date

11-04-2025

Latest Decision Or Authorization Date

14-01-2026

Processing Time Days

279

Number Of Sites

16

Number Of Participants

390

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France