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

NCT06547892 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-13

No results posted yet for this 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.

Conditions

  • Critical Illness

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.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Matheus Silva · Hospital do Coracao

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2025-10-10
Completion
2025-12-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547892 on ClinicalTrials.gov