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 range18 Years – 80 Years

SexALL

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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…

What they're measuring

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

Trial details

NCT IDNCT04531579

SponsorWestat

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06