Systematic Adjunction of Vasopressine in Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vasopressin administration, Sodium chloride administration.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Systematic Adjunction of Vasopressine in Hyperkinetic Septic Shock Patients - A Multicentric RCT
Overview
Septic shock is a syndrome associated with severe infection and a mortality rate of approximately 45%. In line with current recommendations, norepinephrine is the first-line vasopressor used in patients with septic shock. In a previous study, norepinephrine doses above 1 µg/kg/min were associated with mortality rates over 90%. In the same study, doses above 0.3 µg/kg/min were associated with a mortality rate of 40%. An increased mortality compared to the general 40% mortality of septic shock appears to be associated with norepinephrine doses as low as 0.3 µg/kg/min. Vasopressin stimulates V1 receptors, primarily located on vascular smooth muscle cells. When V1a receptors are stimulated, they induce vasoconstriction by activating protein kinase C via a Gq protein and various second messengers. Its use is validated in refractory shock states by international guidelines as a second-line vasopressor. This indication was further reinforced in the 2021 update of the septic shock management recommendations. The VASST study, a randomized controlled trial, assessed the effects of vasopressin versus norepinephrine in septic shock. It found no overall difference in mortality between the two groups. However, in less severe cases where norepinephrine doses were below 14 µg/min before randomization, vasopressin was associated with significantly lower mortality, suggesting potential benefits from early introduction of a second vasopressor. The VANISH trial failed to confirm this hypothesis, possibly due to broad inclusion criteria and unclear protocol regarding the combined use of both agents. Our hypothesis is that (1) vasopressin is beneficial when used synergistically with norepinephrine; (2) due to its negative effect on cardiac output (as shown in previous studies), vasopressin should only be administered to patients in the hyperdynamic phase of septic shock. The hypothesis is that the systematic addition of vasopressin to norepinephrine therapy in a hyperdynamic septic shock subpopulation would improve patient outcomes.
Interventions
- Drug Vasopressin administration
Low dose of vasopressin (0.02ui /min), maximum 5 days - Drug Sodium chloride administration
NaCl 0.9 %, maximum 5 days
Primary outcome measures
- SOFA score comparison between the two groups [Time frame: 48 hours after administration of experimental drug (H48)]
Secondary outcome measures (12)
- SOFA score comparison between the two groups [Time frame: 120 hours after administration of experimental drug (H120)]
- Mortality comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Lactatemia decrease comparison between the two groups [Time frame: Between administration of experimental drug (H0), 24 hours after (H24), and 48 hours after (H48)]
- Noradrenaline use comparison between the two groups [Time frame: 5 days after administration of experimental drug (D5)]
- Renal function comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Respiratory function comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of myocardial ischemia comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of cardiogenic shock comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of mesenteric ischemia comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of digital ischemia comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of atrial fibrillation comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
- Occurrence of a thromboembolic event comparison between the two groups [Time frame: 28 days after administration of experimental drug (D28)]
Eligibility criteria
Inclusion criteria
- Patient aged 18 or over
- Patient who has consented to take part in the research or patient whose close relative has consented to take part in the research or, failing that, patient being included in an emergency situation
- Patient in septic shock with adapted cardiac output
- Patient in whom noradrenaline dosage has been greater than 0.3μg/kg/min for less than 12 hours
- Patients benefiting from or affiliated to social security
Exclusion criteria
- Patient with acute coronary syndrome
- Patient with known history of acute coronary syndrome
- Patient with suspected mesenteric ischemia
- Patient with hyponatremia < 130mmol/L,
- Known allergy to vasopressin or its excipients
- Minors
- Pregnant women
- Patients under legal guardianship or curatorship
- Patients under judicial protection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Assistance Publique - Hôpitaux de Marseille — Marseille
Identifiers
NCT: NCT07052084 · RCAPHM23_0465 · 2024-513401-31-00