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Systematic Adjunction of Vasopressine in hyperkinetic Septic Shock patients: a prospective, randomized, double blind study.
EU CTIS ID: 2024-513401-31-00
What this study is testing
Study the effect of adding vasopressin in hyperkinetic septic shock on organ failure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient 18 years of age or older
- 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
- 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%
- Patients whose noradrenaline dosage has been greater than 0.3µg/kg/min for less than 12 hours at the time of inclusion
- Patients benefiting from or affiliated to a social security system
You likely can't join if
- Patient moribund at inclusion with noradrenaline dose > 1µg/kg/min
- Patient with acute coronary syndrome defined by increased troponin and ST-segment elevation on ECG
- Patients with a known history of recent acute coronary syndrome (< 3 months)
- Patient with suspected mesenteric ischemia
- 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
- Persons who do not speak French
See the full eligibility criteria
- Patient 18 years of age or older
- 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
- 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%
- Patients whose noradrenaline dosage has been greater than 0.3µg/kg/min for less than 12 hours at the time of inclusion
- Patients benefiting from or affiliated to a social security system
- Patient moribund at inclusion with noradrenaline dose > 1µg/kg/min
- Patient with acute coronary syndrome defined by increased troponin and ST-segment elevation on ECG
- Patients with a known history of recent acute coronary syndrome (< 3 months)
- Patient with suspected mesenteric ischemia
- 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
- Persons who do not speak French
- Persons unable to read or write
- 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)
- Patient with hyponatremia < 130mmol/L
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.