A Phase 4 interventional study of vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min and vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min in Septic Shock and Renal Function Replacement, sponsored by Azienda Usl di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Azienda Usl di Bologna · Phase 4, Interventional, and Prevention
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.
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. The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission.
Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups:
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 264 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Azienda Usl di Bologna is the lead sponsor of 40 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure \>65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min
Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.
Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min
when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure \>65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP
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.
Time frame: 7 days
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
Time frame: 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;
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 7 days since enrollment
Length of stay in ICU
Length of stay in ICU (days) will be compared between study and control group
Time frame: 28 and 90 days
Mortality
Mortality at 28 and 90 days will be evaluated for every subject and between study and control group
Time frame: 28 and 90 days
Plan to share: Undecided
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Azienda Usl di Bologna