Using Vasopressin to Prevent Kidney Injury in ICU Patients

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

This study is testing whether vasopressin can help prevent kidney injury in critically ill patients in the ICU.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital do Coracao (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06547892 on ClinicalTrials.gov

What this trial studies

This pilot study is a multicenter, placebo-controlled, double-blind, randomized clinical trial aimed at evaluating the feasibility of using vasopressin to prevent acute kidney injury in critically ill patients admitted to intensive care units (ICUs). The study will include 60 adult patients across 3 to 4 Brazilian hospitals, focusing on those at high risk for renal dysfunction. By assessing adherence to the protocol and monitoring potential adverse effects, the study seeks to provide insights that could lead to larger trials and improved renal outcomes in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adult patients admitted to ICUs with a predicted risk of acute kidney injury of 5 points or more.

Not a fit: Patients who have been in the ICU for more than 24 hours or those with severe conditions such as chronic kidney disease requiring dialysis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic strategies for preventing acute kidney injury in critically ill patients, potentially reducing morbidity and mortality.

How similar studies have performed: While this approach is novel and unprecedented in the literature, similar studies have shown promise in exploring interventions for acute kidney injury prevention.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

São Paulo, São Paulo

• Matheus Liguori Feliciano da Silva — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Matheus Silva — Hospital do Coracao
• Study coordinator: Matheus Silva

Conditions Critical Illness