Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU

Condition(s) studied

Investigational drug(s) / intervention(s)

Vasopressin: 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.

0,9% saline solution: Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.

Study 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

Primary outcome measure(s)

• Feasibility — 6 months
  Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months

Trial sites (1)

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