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

NCT06471231 | Recruiting Phase 4

• 1 other identifier: 23171 - EVSS
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Renal Function Replacement

Keywords

vasopressin; norepinephrine; renal function replacement; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• early association of vasopressin improves renal function

  7 days

• rly addition of vasopressin modifies renal perfusion

  7 days

• addition of vasopressin modifies the fluid balance of patients

  48 and 72 hours

• early combined treatment with vasopressin reduces the duration of the need for CRRT

  7 days

• early association of vasopressin reduces the onset of supraventricular arrhythmias

  7 days

Study Arms (2)

Group A

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

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

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

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Central Study Contacts

Lorenzo Giuntoli, Md

CONTACT

0516478868; lorenzo.giuntoli@ausl.bologna.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: An expert nephrology consultant has been included among the investigators to assess the need for CRRT according to KDIGO criteria, and he will be blinded to the subject allocation. In addition, the physicians who will perform ultrasound evaluation will be blinded to the subject allocation, in order to reduce the potential bias of overestimating the efficacy of the study treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 14, 2024
• First Posted: June 24, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-05

Locations

IT (1)