Clinical trial NCT06547892: Use of Vasopressin in Patients at High Risk of Acute Kidney Injury 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Critical Illness
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical, multicenter, placebo-controlled, double-blind, randomized and feasibility trial with a proposal to include 60 patients in 3 to 4 research centers.
Primary purpose: PREVENTION

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 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.

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 Brazilian hospitals, covering both public and private healthcare profiles across various states of Brazil. Most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research.

The objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (ICUs) can prevent the condition (acute kidney dysfunction).

This study is based on the null hypothesis (H0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (H1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to ICUs. The primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.

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.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Creatinine, in mg/dL
timeFrame: 7 days
Other outcomes:
measure: Mortality
timeFrame: 30 days
Locations:
city: São Paulo
country: Brazil
facility: Matheus Liguori Feliciano da Silva
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Matheus Silva
role: PRINCIPAL_INVESTIGATOR
References: