The Val-CARD Trial
Research type
Research Study
Full title
A RANDOMISED CONTROLLED TRIAL OF PRE-SURGERY SODIUM VALPROATE, FOR THE PREVENTION OF ORGAN INJURY IN CARDIAC SURGERY: THE Val-CARD TRIAL
IRAS ID
246126
Contact name
Gavin Murphy
Contact email
Sponsor organisation
University of Leicester
Eudract number
2018-002076-41
Duration of Study in the UK
3 years, 3 months, 0 days
Research summary
The Val-CARD trial tries 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 commonly used in the treatment of epilepsy. Recently it has been shown to protect against heart and kidney damage in laboratory tests. This has led to trials evaluating whether it can prevent heart and kidney damage in patients. We wish to evaluate whether sodium valproate can reduce levels of organ damage following cardiac surgery. We think that valproate works by making cells in the heart and kidney more resistant to any injury that they suffer during surgery due to the heart lung machine.
This will be an unblinded randomised controlled trial. It will have two parts.
• In the first part patients awaiting cardiac surgery will be allocated at random to one of 4 groups. Depending on which group they will be assigned to receive either no treatment (i.e., Standard Care - Group A), treatment with 15mg/kg Sodium Valproate for 1-2 weeks (Group B), treatment with 15mg/kg Sodium Valproate for for 4-6 weeks (Group C) or 25mg/kg Sodium Valproate for 4-6 weeks before their surgery. The aim of this part of the trial is to find a sodium valproate dose that produces changes in blood cells that are associated with resistance to injury, but that has the fewest side-effects.
• In the second part of the trial we will compare our selected sodium valproate dose to the current standard of care, which is no treatment. We will then compare markers of kidney and heart injury in blood between the patients treated with sodium valproate and those receiving standard care to establish whether sodium valproate may have benefits.REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0188
Date of REC Opinion
23 Aug 2018
REC opinion
Further Information Favourable Opinion