Epilepsy drug may protect organs during heart surgery — trial tests the idea
NCT ID NCT03825250
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether sodium valproate, a drug used for epilepsy, can reduce damage to the heart and kidneys in adults undergoing heart surgery with a heart-lung machine. Participants receive the drug for one to six weeks before their operation, and researchers measure organ injury through blood tests, exercise tests, and other assessments. The goal is to see if the drug makes organs more resistant to the stress of surgery, potentially lowering the risk of complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sodium valproate, an epilepsy drug, given before surgery to see if it protects the heart and kidneys from damage during cardiac surgery.
- What this could lead to
- If it works, this could lead to a simple pre-surgery treatment that reduces organ damage and complications in heart surgery patients.
- What could go wrong
- This is an early-phase trial with a small number of patients, so results may not be conclusive. Sodium valproate can have side effects, and its benefit in this setting is unproven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
45 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
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Nov 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass (CPB). * Able, in the opinion of the investigator, and willing to give informed consent. Exclusion Criteria: * Emergency or salvage procedure * Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) \<15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation. * Patients with persistent or chronic atrial fibrillation. * Patients with acute liver disease. * Personal or family history of severe hepatic dysfunction, especially drug related. * Patients allergic to sodium valproate. * Patients with thrombocytopaenia (platelet count \<150x109 per mL). * Patients taking long-term Histone Deacetylase Inhibitors such as sodium valproate. * Patients taking any of the following medications: antipsychotics, MAO inhibitors, antidepressants and benzodiazepines, Lithium, Olanzepine, Phenobarbital, Primidone, Phenytoin, Carbamazepine, Lamotrigine, Felbamate. * Patients diagnosed with a mitochondrial deficiency disorder. * Patients with porphyria. * Patients with known urea cycle disorders. * Women of child bearing potential (WOCBP) are excluded from the study. A woman is defined as being of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Patients who are participating in another interventional clinical trial. * Unable, in the opinion of the investigator, or unwilling to give informed consent protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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