Status:
RECRUITING
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
Lead Sponsor:
Hospital do Coracao
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ar...
Detailed Description
This is a multicenter, placebo-controlled, double-blind, randomized feasibility clinical trial with a proposal to include 60 patients across 3 to 4 research centers. This study will be conducted in B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06547892
Start Date
April 10 2025
End Date
December 10 2025
Last Update
April 13 2025
Active Locations (1)
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1
Matheus Liguori Feliciano da Silva
São Paulo, São Paulo, Brazil, 03115-001