Renal Outcomes in the early use of vasopressin in the treatment of septic shock

Phase 4

Recruiting

Conditions: Septic shock

Registration Number: 2023-509071-16-00

Lead Sponsor: Azienda Unita Sanitaria Locale Di Bologna

Brief Summary: The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines variations 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 242

Inclusion Criteria

Patients suffering from septic shock hospitalized in an intensive setting within 24 hours of clinical diagnosis

Capable of expressing informed consent to treatment

Aged over 18 years and under 80 years of age

Male and female

Norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)

Exclusion Criteria

Patients in the absence of consent to participate in the study and to the processing of personal and particular data

Patients with allergy/intolerance to the drugs used in the study

Pregnant patients

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)

Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time

Single kidney patients

Patients with bilateral renal hypoplasia

Patients undergoing kidney transplant

Patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin

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)

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30% reduction of patients satisfying the criteria for CRRT within the study group.		30% reduction of patients satisfying the criteria for CRRT within the study group.

Secondary Outcome Measures

Name	Time	Method
Reduction of maximum KDIGO class reached in the first 7 days of hospitalization		Reduction of maximum KDIGO class reached in the first 7 days of hospitalization
Evaluation of renal perfusion using the CEUS method carried out within 24 hours of enrollment and 72 hours after the first evaluation (in terms of the presence of ischemic areas, their number and size		Evaluation of renal perfusion using the CEUS method carried out within 24 hours of enrollment and 72 hours after the first evaluation (in terms of the presence of ischemic areas, their number and size
Water balance 24, 48, 72 hours after admission to the ICU		Water balance 24, 48, 72 hours after admission to the ICU
Number of patients meeting criteria for RRT during ICU stay		Number of patients meeting criteria for RRT during ICU stay
Number of patients who develop AF, atrial flutter or PSVT lasting more than 30 minutes and who require the introduction of new drugs for rate or rhythm control or electrical cardioversion within 24 hours of arrhythmic onset		Number of patients who develop AF, atrial flutter or PSVT lasting more than 30 minutes and who require the introduction of new drugs for rate or rhythm control or electrical cardioversion within 24 hours of arrhythmic onset
Number of patients who present intestinal ischemia or extremity ischemia during the infusion of vasoactive drugs or within 3 days after the end of the administration of the aforementioned drugs		Number of patients who present intestinal ischemia or extremity ischemia during the infusion of vasoactive drugs or within 3 days after the end of the administration of the aforementioned drugs
Length of stay in ICU and mortality at 28 and 90 days		Length of stay in ICU and mortality at 28 and 90 days

Trial Locations

Locations (1): Azienda Unita Sanitaria Locale Di Bologna
🇮🇹
Bologna, Italy
Azienda Unita Sanitaria Locale Di Bologna
🇮🇹Bologna, Italy
Lorenzo Giuntoli
Site contact
0516478868
lorenzo.giuntoli@ausl.bologna.it