ARGIPRESSIN for Septic shock

Inclusion criteria

• {"criterion_text":"- Patient 18 years of age or older"}
• {"criterion_text":"- Patient who has consented to participate in the research or patient whose close relative has consented to participate in the research or, failing that, patient being included in an emergency situation"}
• {"criterion_text":"- Patient in septic shock with adapted cardiac output defined by : a proven or suspected infectious call point justifying antibiotic therapy ; lactatemia > 2.0 mmol/L ; noradrenaline dosage greater than 0.3 µg/kg/min for more than one hour to maintain mean arterial pressure greater than 65 mmHg despite volumetric correction ; adequate cardiac output defined by a cardiac index ≥ 3.0 L/min/m² or central venous oxygen saturation (ScvO2) ≥ 70%"}
• {"criterion_text":"- Patients whose noradrenaline dosage has been greater than 0.3µg/kg/min for less than 12 hours at the time of inclusion"}
• {"criterion_text":"- Patients benefiting from or affiliated to a social security system"}

Exclusion criteria

• {"criterion_text":"- Patient moribund at inclusion with noradrenaline dose > 1µg/kg/min"}
• {"criterion_text":"- Patient with acute coronary syndrome defined by increased troponin and ST-segment elevation on ECG"}
• {"criterion_text":"- Patients with a known history of recent acute coronary syndrome (< 3 months)"}
• {"criterion_text":"- Patient with suspected mesenteric ischemia"}
• {"criterion_text":"- Patients with a known allergy to vasopressin (REVERPLEG 40 I.U./2 mL, dilutable solution for infusion) or to one or more of its excipients"}
• {"criterion_text":"- Persons who do not speak French"}
• {"criterion_text":"- Persons unable to read or write"}
• {"criterion_text":"- Patients covered by articles L. 1121-5 to L. 1121-8 of the French Public Health Code (minors, adults under tutorship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women)"}
• {"criterion_text":"- Patient with hyponatremia < 130mmol/L"}

Primary endpoints

• {"endpoint_text":"- Difference in SOFA score 48 hours after drug administration between the 2 groups","definition_or_measurement_approach":"SOFA score measured 48 hours after administration of the investigational drug; primary measure is the difference in SOFA score at 48 hours between the two randomized groups."}

Secondary endpoints

• {"endpoint_text":"- SOFA score at D5","definition_or_measurement_approach":"SOFA score measured on Day 5"}
• {"endpoint_text":"- All-cause mortality in ICU (date of death) and all-cause mortality at D28 (date of death)","definition_or_measurement_approach":"All-cause mortality recorded in ICU and at Day 28 with date of death"}
• {"endpoint_text":"- Plasma lactatemia clearance between introduction of experimental drug (H0) and H24 and H48","definition_or_measurement_approach":"Change/clearance in plasma lactate concentration measured at baseline (H0), H24 and H48"}
• {"endpoint_text":"- K-DIGO classification at D28 for severity","definition_or_measurement_approach":"KDIGO classification of acute kidney injury severity assessed at Day 28"}
• {"endpoint_text":"- Use of extrarenal purification at D28 (yes/no), number of days alive without extrarenal purification at D28","definition_or_measurement_approach":"Binary assessment of use of extracorporeal renal replacement therapy at Day 28 and count of days alive without such therapy to Day 28"}
• {"endpoint_text":"- Number of days alive without mechanical ventilation at D28","definition_or_measurement_approach":"Count of days alive and free of mechanical ventilation up to Day 28"}
• {"endpoint_text":"- Maximum dose of noradrenaline during the first 5 days of inclusion defined as the maximum dose of noradrenaline infusion","definition_or_measurement_approach":"Maximum recorded noradrenaline infusion rate during the first 5 days of inclusion"}
• {"endpoint_text":"- Number of days alive without noradrenaline infusion at D28","definition_or_measurement_approach":"Count of days alive and free of noradrenaline infusion up to Day 28"}
• {"endpoint_text":"- Occurrence of myocardial ischemia defined as electrocardiogram (ECG) change with ST-segment elevation associated with >100% rise in plasma ultrasensitive troponin concentration, between inclusion and D28","definition_or_measurement_approach":"Event-based endpoint: ECG change with ST elevation plus >100% rise in ultrasensitive troponin between inclusion and Day 28"}
• {"endpoint_text":"- Occurrence of cardiogenic shock defined as a left ventricular ejection fraction below 30% and the need to introduce a positive inotropic drug, between inclusion and D28","definition_or_measurement_approach":"Event-based: LVEF <30% with need for positive inotrope between inclusion and Day 28"}
• {"endpoint_text":"- Occurrence of mesenteric ischemia defined as the occurrence of an intestinal vascular disorder requiring surgical management (vascular bypass or stent, digestive resection), between inclusion and D28","definition_or_measurement_approach":"Event-based: mesenteric ischemia requiring surgical intervention between inclusion and Day 28"}
• {"endpoint_text":"- Occurrence of digital ischemia defined as clinical skin necrosis of the extremities of the upper and lower limbs, between inclusion and D28","definition_or_measurement_approach":"Event-based: clinical skin necrosis of extremities between inclusion and Day 28"}
• {"endpoint_text":"- Occurence of atrial fibrillation defined as irregular tachycardia with fine QRS of atrial origin, between inclusion and D28","definition_or_measurement_approach":"Event-based: onset of atrial fibrillation (irregular tachycardia with fine QRS of atrial origin) between inclusion and Day 28"}
• {"endpoint_text":"- Occurrence of a thromboembolic event defined by the presence of deep vein thrombosis or pulmonary embolism, between inclusion and D28","definition_or_measurement_approach":"Event-based: confirmed DVT or PE between inclusion and Day 28"}

France

Earliest CTIS Part Ii Submission Date

17-04-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

183

Number Of Sites

6

Number Of Participants

120

Primary sponsor

Full Name

Centre Hospitalier Regional De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France