Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients (NCT04531579) | Clinical Trial Compass
WithdrawnPhase 2
Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients
Stopped: Study terminated by the Sponsor.
United States0Started 2022-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is aged 18 to 80 years old;
* Is male or non-pregnant, non-breastfeeding female;
* Is able to provide written informed consent or has an LAR from whom consent can be obtained;
* Body mass index (BMI) is between 18 kg/m2 and 35 kg/m2;
* Injuries or underlying medical problems are considered likely survivable by the attending trauma physician on initial evaluation; and
* Experienced blunt or penetrating trauma that resulted in bleeding with at least two systolic blood pressure (SBP) readings ≤100 mmHg at any point during transport to the ED or during the Screening period. SBP readings of ≤100 mmHg need not be consecutive.
Exclusion Criteria:
* Has a known history of adverse reaction to VPA;
* Is currently receiving VPA;
* Is pregnant or breastfeeding;
* Has inadequate venous access;
* Is in need of a kidney transplant, or currently on RRT for either AKI or hepato-renal syndrome, type I (HRS-I);
* Is known to have mitochondrial disorders caused by polymerase γ (POLG) mutations;
* Is currently incarcerated or pending incarceration;
* Is being transferred/transported from a referring facility and 1) spent more than 1 hour at the referring facility or 2) received any surgical or I/R procedure for hemorrhage control. (Blood transfusions and minor ED procedures, i.e., tourniquet placement, chest tube placement, etc. are not exclusionary);
* Has a known history of hepatic dysfunction (defined as Model for End-Stage Liver Disease (MELD) score \>15), pancreatiti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stage of AKI as assessed by Kidney Disease: Improving Global Outcomes (KDIGO) stage based on serum creatinine (SCr)
Timeframe: Within the first 48 hours after study drug administration