Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients
Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Westat
Collaborators:
Clinipace Worldwide United States Department of Defense