HYDRA-P
Research type
Research Study
Full title
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
IRAS ID
186752
Contact name
Athanasios Saratzis
Contact email
Sponsor organisation
Research Governance, University of Leicester
Eudract number
2015-003073-15
Duration of Study in the UK
1 years, 0 months, 28 days
Research summary
Abdominal aortic aneurysm (AAA) constitutes a significant health problem, with current prevalence rates for men above the age of 65 ranging from 1.3% to 7.2% in the Western World. Endovascular abdominal aortic aneurysm repair (EVAR), a minimally invasive alternative to the traditional open repair, is now the recommended first-line treatment for patients with an AAA. However, those undergoing EVAR are at high risk of developing acute kidney injury (AKI), an acute dysfunction of their kidneys, at an incidence rate of almost 20% based on our recent data. This is because EVAR requires the administration of contrast agents that are toxic to the kidneys and can additionally cause direct kidney damage via several other mechanisms. AKI is associated with morbidity, prolonged length of hospital stay, and cost. Long-term survival and incidence of cardiovascular events are also directly affected by AKI following EVAR. We recently calculated, based on our multicentre data from EVAR-registries, that AKI after EVAR in the UK translates to an annual cost of £2,378,961 for the NHS. Subsequently, AKI prevention is important to both maximize the patient-benefits of EVAR and reduce treatment-costs. However, there is significant lack of evidence in terms of how AKI can be prevented in patients undergoing EVAR. The majority of the literature consists of under-powered studies with inconsistent definitions and important flaws. Based on the findings of this prospective pilot-feasibility study we hope to design a multicentre randomized study to examine the administration of intra-venous bicarbonate (a simple, safe and cheap intervention) and peri-operative hydration as a way of preventing AKI and renal damage during elective EVAR. The pilot-feasibility stage will inform us regarding tolerability of the intervention, feasibility in terms of uptake and number of centres required as well as subsequent sample-size calculations and will provide information regarding the mechanistic effects of our intervention.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0008
Date of REC Opinion
12 Feb 2016
REC opinion
Further Information Favourable Opinion