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Systematic Adjunction of Vasopressine in hyperkinetic Septic Shock patients: a prospective, randomized, double blind study.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513401-31-00
Acronym
RCAPHM23_0465
Enrollment
120
Registered
2025-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Brief summary

Difference in SOFA score 48 hours after drug administration between the 2 groups

Detailed description

SOFA score at D5, All-cause mortality in ICU (date of death) and all-cause mortality at D28 (date of death), Plasma lactatemia clearance between introduction of experimental drug (H0) and H24 and H48, K-DIGO classification at D28 for severity, Use of extrarenal purification at D28 (yes/no), number of days alive without extrarenal purification at D28, Number of days alive without mechanical ventilation at D28, Maximum dose of noradrenaline during the first 5 days of inclusion defined as the maximum dose of noradrenaline infusion, Number of days alive without noradrenaline infusion at D28, 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, 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, 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, Occurrence of digital ischemia defined as clinical skin necrosis of the extremities of the upper and lower limbs, between inclusion and D28, Occurence of atrial fibrillation defined as irregular tachycardia with fine QRS of atrial origin, between inclusion and D28, Occurrence of a thromboembolic event defined by the presence of deep vein thrombosis or pulmonary embolism, between inclusion and D28

Interventions

Sponsors

Centre Hospitalier Regional De Marseille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in SOFA score 48 hours after drug administration between the 2 groups

Secondary

MeasureTime frame
SOFA score at D5, All-cause mortality in ICU (date of death) and all-cause mortality at D28 (date of death), Plasma lactatemia clearance between introduction of experimental drug (H0) and H24 and H48, K-DIGO classification at D28 for severity, Use of extrarenal purification at D28 (yes/no), number of days alive without extrarenal purification at D28, Number of days alive without mechanical ventilation at D28, Maximum dose of noradrenaline during the first 5 days of inclusion defined as the maximum dose of noradrenaline infusion, Number of days alive without noradrenaline infusion at D28, 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, 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, Occurrence of mesenteric ische

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026