Using vasopressin early in septic shock treatment

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

This study is testing if giving vasopressin early along with norepinephrine can help improve kidney function in patients with septic shock.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Azienda Usl di Bologna (Government)
• Locations: 1 site (Bologna)
• Trial ID: NCT06471231 on ClinicalTrials.gov

What this trial studies

This study investigates whether the early use of vasopressin in conjunction with norepinephrine improves renal function outcomes in patients experiencing septic shock. Patients will be randomized into two groups: one receiving vasopressin when norepinephrine dosage reaches 0.25 mcg/kg/min, and the other receiving it only when norepinephrine exceeds 0.5 mcg/kg/min. The primary focus is to assess the need for renal function replacement techniques within the first week of ICU admission. This approach aims to determine if earlier intervention can lead to better renal outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who are hospitalized with septic shock and require norepinephrine treatment.

Not a fit: Patients who are under 18 or over 80 years old, or those who do not require norepinephrine at the specified dosage, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved renal function and reduced need for dialysis in patients with septic shock.

How similar studies have performed: Previous studies have explored the use of vasopressin in septic shock, but this specific early intervention approach is novel.

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.

Where this trial is running

Bologna

• Azienda Unità Sanitaria Locale — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Lorenzo Giuntoli, Md

Conditions Septic Shock; Renal Function Replacement; vasopressin; norepinephrine; renal function replacement