Clinical trial NCT06471231: Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
Official title: Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Septic Shock
Renal Function Replacement
Keywords: vasopressin
norepinephrine
renal function replacement
Septic Shock
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-06-24
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 30% or more reduction in terms of the use of renal function replacement
timeFrame: 7 days
Secondary outcomes:
measure: early association of vasopressin improves renal function
timeFrame: 7 days
measure: rly addition of vasopressin modifies renal perfusion
timeFrame: 7 days
measure: addition of vasopressin modifies the fluid balance of patients
timeFrame: 48 and 72 hours
measure: early combined treatment with vasopressin reduces the duration of the need for CRRT
timeFrame: 7 days
measure: early association of vasopressin reduces the onset of supraventricular arrhythmias
timeFrame: 7 days
measure: intestinal and/or digital and/or limb ischemia;
timeFrame: 7 days since enrollment
measure: Length of stay in ICU
timeFrame: 28 and 90 days
measure: Mortality
timeFrame: 28 and 90 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria Locale
Study officials:
References: