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

NCT06547892 | Recruiting Phase 2

• 1 other identifier: NOVA-AKI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months

  6 months

Secondary Outcomes (1)

• Creatinine, in mg/dL

  7 days

Other Outcomes (1)

• Mortality

  30 days

Study Arms (2)

Vasopressin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.

Other: 0,9% saline solution

Interventions

Vasopressin DRUG

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.

Vasopressin

0,9% saline solution OTHER

Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Time since admission to the ICU greater than 24 hours;
• 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;
• Pregnancy.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Matheus Liguori Feliciano da Silva

São Paulo, São Paulo, 03115-001, Brazil

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Matheus Silva

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matheus Silva

CONTACT

+55 11 98282-3920; matheus_liguori@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization list will be generated with appropriate software, in blocks of 4, by a statistician not involved in patient care. There will be stratification by center. Randomization confidentiality will be guaranteed by central randomization via REDCap.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical, multicenter, placebo-controlled, double-blind, randomized and feasibility trial with a proposal to include 60 patients in 3 to 4 research centers.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: April 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: December 10, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 20 months

Locations

BR (1)