Status:
UNKNOWN
The Val-CARD Trial
Lead Sponsor:
University of Leicester
Conditions:
Cardiac Valve Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The Val-CARD trial aims to answer the question: "Does the drug sodium valproate reduce complications affecting the heart and kidneys in patients having heart operations?" Sodium valproate is a drug co...
Detailed Description
This trial is a single centre, unblinded, randomised controlled trial of pre-surgery sodium valproate versus standard care (no treatment). The trial has two phases. In the first phase - the dose findi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03825250
Start Date
November 6 2018
End Date
October 7 2024
Last Update
November 13 2023
Active Locations (1)
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1
Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP