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Epilepsy drug may protect organs during heart surgery — trial tests the idea

NCT ID NCT03825250

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Nov 2023

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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