The Val-CARD Trial

Launched by UNIVERSITY OF LEICESTER · Jan 30, 2019

Keywords

ClinConnect Summary

The Val-CARD Trial is a research study looking at whether the medication sodium valproate can help protect the heart and kidneys from damage during heart surgeries. Sodium valproate is usually used to treat epilepsy, but lab tests have suggested it might also prevent harm to these vital organs during surgery. The trial will involve patients who are scheduled for heart surgery, and researchers will closely monitor their health through blood tests, exercise assessments, and other methods after the surgery to see if the medication makes a difference.

To be eligible for this trial, participants need to be adults (18 years or older) who are having certain types of heart surgery that require the use of a heart-lung machine. However, some individuals, such as those with severe kidney issues, certain heart conditions, or those taking specific medications, may not be able to participate. If someone joins the trial, they will receive sodium valproate for a short time around their surgery, and the research team will be there to support them and gather important information about their recovery.

Gender

ALL

Eligibility 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.