Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock

Azienda Usl di Bologna264 enrolled

Overview

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: * 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. * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

264

Conditions

Septic Shock Renal Function Replacement

Interventions

vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/minDRUG

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.

vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/minDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients suffering from septic shock hospitalized in an intensive setting * patients over 18 years and under 80 years of age * patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW) * patients capable of expressing informed consent to treatment. Exclusion Criteria: * patients in the absence of consent to participate in the study and to the processing of personal and particular data; * patients under 18 years of age or over 80 years of age; * patients who died within the first 24 hours of admission to the ICU; * patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU; * patients with recent acute coronary syndrome (within the previous 7 days); * patients with allergy/intolerance to the drugs used in the study or to any component of the study drug including excipients; * pregnant patients; * breastfeeding individuals; * patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred; * patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration \< 30 ml/min); * single kidney patients; * patients with bilateral renal hypoplasia; * patients undergoing kidney transplant; * patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin.

Locations (1)

Azienda Unità Sanitaria Locale

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Lorenzo Giuntoli, Md

CONTACT

0516478868 lorenzo.giuntoli@ausl.bologna.it

Data from ClinicalTrials.gov

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