Who is sponsoring NCT04531579?

NCT04531579 is sponsored by Westat.

What condition does NCT04531579 study?

NCT04531579 studies Acute Kidney Injury, Ischemia Reperfusion Injury.

What drugs are being tested in NCT04531579?

Interventions: Valproic Acid Solution, Isotonic saline solution.

What is the status of NCT04531579?

NCT04531579 is currently WITHDRAWN.

Last reviewed 2021-10-27 · How we verify

Evaluation of Valproic Acid (VPA) as Adjunctive Therapy for Trauma Patients With Moderate to Severe Hemorrhage at Risk of Ischemia Reperfusion (I/R) Injury

NCT04531579 Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Westat
Phase	Phase 2
Status	WITHDRAWN
Start date	2022-01
Completion	2023-06

Conditions

Acute Kidney Injury
Ischemia Reperfusion Injury

Interventions

Valproic Acid Solution
Isotonic saline solution

Primary outcomes

Stage of AKI as assessed by Kidney Disease: Improving Global Outcomes (KDIGO) stage based on serum creatinine (SCr) — Within the first 48 hours after study drug administration
The primary endpoint of AKI as assessed by KDIGO stages will be measured in ordinal scale as 0, 1, 2, or 3, where 0 indicates normal renal function and the progressively higher values indicate worsening renal function

Countries

United States