Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU: a Feasibility Randomized Clinical Trial
Hospital do Coracao
60 participants
Apr 10, 2025
INTERVENTIONAL
Conditions
Summary
Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.
Eligibility
Inclusion Criteria3
- Adult patients (≥18 years old);
- Admitted to intensive care units;
- Predicted risk of acute kidney injury calculated based on clinical and laboratory data at ICU admission and is considered eligible if the value in the calculator is equal or greater than 5 points;
Exclusion Criteria12
- Time since admission to the ICU greater than 24 hours;
- Use of vasopressors at the time of inclusion;
- MAP >90 mmHg;
- Hyponatremia (<130 mmol/L);
- Severe TBI with Glasgow Coma Scale < 8;
- Elective surgeries;
- Dialysis chronic kidney disease or acute kidney injury who received renal replacement therapy upon admission or are expected to receive renal replacement therapy within the next 24 hours;
- Suspected or confirmed acute mesenteric ischemia;
- Prospect of death in less than 24 hours;
- Medical team not committed to full investment at the time of inclusion;
- Prior inclusion in the study;
- Pregnancy.
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Interventions
To dilute vasopressin, an ampoule containing 20 IU/ml (1 ml) of vasopressin will be used, which will be mixed with 100 ml of 0.9% physiological solution, resulting in a solution with a concentration of 0.2 IU/ ml. In this study, both central and peripheral vein infusion will be permitted. The vasopressin administration protocol will consist of an initial dose of 0.02 IU/min (equivalent to 6 ml/h), which can be increased to 0.03 IU/min (9 ml/h) if the mean arterial pressure (MAP) is less than or equal to 65 mmHg. On the other hand, if MAP exceeds 90 mmHg, the dose can be reduced to 0.01 IU/min (3 ml/h). The minimum period for adjusting the drug dosage should be one hour.
Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06547892