Abstract: TH-PO1183
Kidney Protection Using the RenalGuard® System in Cardiac Surgery (KIDNEY Study): A Randomised Control Trial Assessing AKI Rate
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- No subcategory defined
Authors
- Luckraz, Heyman, American Hospital Dubai, Dubai, United Arab Emirates
- Giri, Ramesh, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Wrigley, Benjamin John, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Nagarajan, Kumaresan, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Beare, Lawrence, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Senanayake, Eshan, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Sharman, Emma Louise, The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom
- Nevill, Alan M, University of Wolverhampton, Walsall, United Kingdom
Background
Acute kidney injury (AKI) after cardiac surgery occurs in up to 30% of patients & is associated with significant morbidity & mortality. RenalGuard® system (RG) has been shown to reduce AKI rates in patients undergoing Percutaneous Cardiac Intervention (PCI, TAVR). This study investigated the efficacy & safety of balanced forced diuresis using the RenalGuard® system in cardiac surgical patients requiring cardiopulmonary bypass (CPB)
Methods
Patients at risk of developing AKI during cardiac surgery (history of diabetes &/or anemia, e-GFR < 60 ml/min/1.73m2, anticipated CPB time > 120 minutes, Log EuroScore >5) were randomized to either RG (n=110) or managed as per current management strategy (control=110). Primary end-point was the development of AKI, defined by RIFLE criteria, within first 3 days of surgery. (Trial registration:NCT02974946)
Results
There were no significant differences in patients’ pre & intra-operative characteristics (age, gender, LVEF, surgery type, Log EuroScore, pre-op creatinine & e-GFR levels, CPB & cross-clamp times & pre-op history of diabetes, peripheral vascular disease & renal impairment) between the 2 groups. Post-operative AKI rates were significantly lower in RG group compared to control (10% (11/110) v/s 20.9% (23/110), p=0.025). Binary logistic regression analysis confirmed RG system to be independently associated with significant AKI reduction (OR 2.82, 95%CI 1.20 – 6.60, p=0.017). The mean volumes of urine produced during surgery (2337+/-896 ml v/s 766+/-557 ml) & within first 24 hours post-op (3297 +/- 1298 ml v/s 2053 +/- 802 ml) were significantly higher in RG group (p<0.01). There was no significant difference in the incidence of blood transfusions, atrial fibrillation, infections, cerebro-vascular events, median ICU and in-hospital stays between the two groups. One patient in the RG group & two patients in the control group died prior to hospital discharge. The number needed to treat (NNT) with the RG system to prevent AKI was 9 patients
Conclusion
In patients at-risk for AKI, undergoing cardiac surgery with the CPB, the RenalGuard® system significantly reduced the incidence of AKI and can be used safely & reproducibly. Larger studies will be required to assess the cost benefit of this device
Funding
- Other NIH Support –