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RECRUITING
NCT06547892
PHASE2

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

Sponsor: Hospital do Coracao

View on ClinicalTrials.gov

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.

Official title: Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU: a Feasibility Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-04-10

Completion Date

2025-12-10

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

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.

OTHER

0,9% saline solution

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

Locations (1)

Matheus Liguori Feliciano da Silva

São Paulo, São Paulo, Brazil