REVAKI-2
Research type
Research Study
Full title
The Effect of Sildenafil (REVATIO®) on Post Cardiac Surgery Acute Kidney Injury: A Randomised, Placebo-controlled Phase IIb Clinical Trial: The REVAKI-2 Trial
IRAS ID
180197
Contact name
Gavin Murphy
Contact email
Sponsor organisation
University of Leicester
Eudract number
2015-003259-24
ISRCTN Number
ISRCTN18386427
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. It affects over 30% of patients and increases the risk of death 10 fold. Despite many decades of research into kidney injury there is no effective treatment. This trial will test whether the drug sildenafil can prevent AKI in cardiac surgery patients. We have demonstrated that sildenafil can prevent acute kidney injury in experimental studies, and more recently we have shown that sildenafil can be administered safely to patients undergoing cardiac surgery in an early clinical trial (REVAKI-1). The REVAKI-1 study also established a dose that can be given during cardiac surgery that achieves plasma concentrations that are known to have clinical effects in other settings. This dose did not have any adverse side-effects. Using this information we have designed a randomised clinical trial to compare this dose with a placebo. This trial will compare levels of kidney function and injury in the two groups, as well as markers of injury in other organ systems that may be protected by sildenafil treatment. Patients will be recruited for the trial via NHS hospitals. It is anticipated that the trial will last for 2.5 years. Patients that are recruited will be followed up until 3 months after cardiac surgery.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0489
Date of REC Opinion
7 Dec 2015
REC opinion
Further Information Favourable Opinion