Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
NCT Number: NCT06471231
Acronym: EVSS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Septic Shock|Renal Function Replacement
Interventions: DRUG: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min|DRUG: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min
Sponsor: Azienda Usl di Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 264
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-15
Completion Date: 2026-05-15
Locations: Azienda Unità Sanitaria Locale, Bologna, 40100, Italy

Summary:
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose.

Primary Outcome Measures: 30% or more reduction in terms of the use of renal function replacement, The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines a 30% or more reduction in terms of the use of renal function replacement techniques in the first 7 days of hospitalization in the Intensive Care Unit (ICU), compared to patients in whom the vasopressin is added only when norepinephrine reaches a higher dosage., 7 days
Secondary Outcome Measures: early association of vasopressin improves renal function, To assess the protective effect of early vasopressin association, the Kidigo score will be calculated for every subject at enrollment time, and daily, for 7 days. The maximum value and the greatest increase will be evaluated and compared between study and control group, 7 days|rly addition of vasopressin modifies renal perfusion, verify whether the early addition of vasopressin modifies renal perfusion assessed ultrasoundally according to the CEUS method;, 7 days|addition of vasopressin modifies the fluid balance of patients, To assess the impact of early vasopressin association on the total amount of fluids administrated in the resuscitative phase of septic shock treatment, the fluid balance at 48 hours and 72 hours since ICU admission will be calculated for every subject, and compared between study and control group., 48 and 72 hours|early combined treatment with vasopressin reduces the duration of the need for CRRT, verify whether early combined treatment with vasopressin reduces the duration of the need for CRRT (Continuous Renal Replacement Therapy) in patients who require such support during hospitalization in the ICU, 7 days|early association of vasopressin reduces the onset of supraventricular arrhythmias, verify whether the early association of vasopressin reduces the onset of supraventricular arrhythmias (atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia) during treatment with vasopressor drugs, 7 days|intestinal and/or digital and/or limb ischemia;, The incidence of intestinal and/or digital and/or limb ischemia during the study period (7 days since enrollment) will be evaluated and compared between study and control group., 7 days since enrollment|Length of stay in ICU, Length of stay in ICU (days) will be compared between study and control group, 28 and 90 days|Mortality, Mortality at 28 and 90 days will be evaluated for every subject and between study and control group, 28 and 90 days