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Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients

NCT04531579 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-29

No results posted yet for this study

Summary

The purpose of this study is to find out if a drug called valproic acid (VPA) will protect organs (such as the kidneys) from damage when a person is injured and loses a large amount of blood. The organs may not get enough blood or oxygen when a patient loses a lot of blood. After the patient receives fluids such as blood, plasma, or saline and the bleeding is stopped, blood and oxygen return to the organs. This process called ischemia/reperfusion (I/R) is known to cause injury to organs such as the kidneys and heart. VPA is an approved drug for treating conditions like seizures and migraines for many years. However, it is not approved for use at the higher dose that will be used in this study or for protecting organs from I/R injury. This study will enroll trauma patients and randomly assign them to receive either VPA diluted in salt water or salt water without VPA (placebo) and then follow the patients and compare their organ function and overall outcome. This study is masked meaning that the patients, doctors, and nurses will not know which patient received which treatment. The study treatment will be given in addition to the care that trauma patients normally receive to treat their injuries. The researchers doing this study believe that VPA will lessen organ injury caused by I/R, meaning that patients who receive VPA will experience less kidney injury when compared to patients who receive the placebo.

Conditions

Interventions

DRUG

Valproic Acid Solution

Valproate sodium in 5-ml single-dose vials containing 100 mg/ml of VPA. The appropriate dose of 140 mg/kg, based on the subject's weight at study entry, will be diluted in isotonic saline solution to a final volume of 300 ml for administration

DRUG

Isotonic saline solution

Isotonic saline solution consisting of 0.9% sodium chloride in the volume of 300 ml for administration

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Clinipace Worldwide

    collaborator INDUSTRY

  • Westat

    lead OTHER

Principal Investigators

  • Cristina Rabadan-Diehl, PharmD, PhD · Westat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531579 on ClinicalTrials.gov