Using sodium valproate to prevent heart and kidney damage during heart surgery
A Randomised Controlled Trial of Pre-surgery Sodium ValpRoate, for the Prevention of Organ Injury in Cardiac Surgery: THE Val-CARD TRIAL
PHASE1; PHASE2 · University of Leicester · NCT03825250
This study is testing if sodium valproate can help protect the heart and kidneys from damage during heart surgery for patients undergoing the procedure.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT03825250 on ClinicalTrials.gov |
What this trial studies
The Val-CARD trial investigates whether sodium valproate, a drug typically used for epilepsy, can reduce complications in patients undergoing heart surgery. This interventional study consists of two phases: the first phase focuses on determining the optimal dosage of sodium valproate, while the second phase evaluates its effectiveness in preventing organ injury compared to standard care. Patients will be randomly assigned to receive either sodium valproate or no treatment prior to surgery, with various assessments conducted to measure organ damage. The trial aims to establish if sodium valproate can enhance the resilience of the heart and kidneys during surgical procedures involving cardiopulmonary bypass.
Who should consider this trial
Good fit: Ideal candidates are adult patients (18 years and older) scheduled for cardiac surgery involving cardiopulmonary bypass.
Not a fit: Patients with end-stage renal failure, acute liver disease, or those allergic to sodium valproate will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of heart and kidney complications in patients undergoing cardiac surgery.
How similar studies have performed: While the use of sodium valproate in this context is novel, preliminary laboratory tests suggest it may protect against organ damage, warranting further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leicester, Leicestershire
- Glenfield Hospital — Leicester, Leicestershire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Marius Roman, MD — Academic Clinical Lecturer in Cardiac Surgery, University of Leicester
- Study coordinator: Marius Roman, MD
- Email: mariusroman@nhs.net
- Phone: +44(0)1162525841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple, Sodium Valproate, Cardiac Surgery, Organ Injury Prevention