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

NCT ID: NCT06471231

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2026-05-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

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 Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Unità Sanitaria Locale

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Giuntoli, Md

Role: CONTACT

lorenzo.giuntoli@ausl.bologna.it

0516478868

Facility Contacts

Lorenzo Giuntoli, Md

Role: primary

lorenzo.giuntoli@ausl.bologna.it

0516478868

Other Identifiers

23171 - EVSS

Identifier Type: -

Identifier Source: org_study_id