NCT06471231

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Septic Shock
• Renal Function Replacement

Interventions

Type	Name	Description
DRUG	vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 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.
DRUG	vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/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

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: Italy