Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU (NOVA-AKI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Drug: Vasopressin; Other: 0,9% saline solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matheus Silva; Phone Number: +55 11 98282-3920; Email: matheus_liguori@hotmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 03115-001
      • Recruiting
      • Matheus Liguori Feliciano da Silva
      • Contact: Matheus Liguori Feliciano da Silva D Silva, MD; Phone Number: 1198282-3920; Email: matheus_liguori@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. In the event that a MAP exceeds 100 mmHg persists, the dose of the drug can be reduced more quickly or even stopped. The duration of vasopressin therapy will be maintained for 7 days, discharge from the ICU, initiation of renal replacement therapy or until death, whichever occurs first.	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.
Placebo Comparator: Placebo; Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.	Other: 0,9% saline solution; Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine, in mg/dL	Creatinine will be defined by laboratory analysis	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality will be defined by medical records	30 days

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Principal Investigator: Matheus Silva, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): December 10, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Renal Insufficiency; Critical Illness; Acute Kidney Injury; Physiological Effects of Drugs; Hemostatics; Coagulants; Natriuretic Agents; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: NOVA-AKI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our data dissemination plan will follow the rules of the research institute (Hcor)
• IPD Sharing Time Frame: 20 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No