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Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
RECRUITINGPhase 4Sponsored by Azienda Usl di Bologna
Actively Recruiting
PhasePhase 4
SponsorAzienda Usl di Bologna
Started2024-05-15
Est. completion2026-05-15
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06471231
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.
Eligibility
Age: 18 Years – 80 YearsHealthy volunteers accepted
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.
Conditions3
DiabetesRenal Function ReplacementSeptic Shock
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Actively Recruiting
PhasePhase 4
SponsorAzienda Usl di Bologna
Started2024-05-15
Est. completion2026-05-15
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06471231