1. Forced diuresis with matched hydration during transcatheter aortic valve implantation for Reducing Acute Kidney Injury: a randomized, sham-controlled study (REDUCE-AKI).
- Author
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Arbel Y, Ben-Assa E, Puzhevsky D, Litmanowicz B, Galli N, Chorin E, Halkin A, Sadeh B, Konigstein M, Bassat OK, Steinvil A, Bazan S, Banai S, and Finkelstein A
- Subjects
- Aged, Aged, 80 and over, Aortic Valve Stenosis surgery, Double-Blind Method, Female, Fluid Therapy methods, Fluid Therapy mortality, Humans, Male, Prospective Studies, Acute Kidney Injury etiology, Acute Kidney Injury prevention & control, Acute Kidney Injury therapy, Aortic Valve surgery, Diuresis, Heart Valve Prosthesis Implantation adverse effects, Postoperative Complications prevention & control, Postoperative Complications therapy
- Abstract
Aims: Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) and is associated with increased risk for short- and long-term mortality. In patients undergoing percutaneous coronary intervention (PCI), forced diuresis with matched hydration has been shown to reduce the incidence of AKI by ∼50%. The aim of the present study was to evaluate whether forced diuresis with matched intravenous hydration reduces AKI in patients undergoing TAVI., Methods and Results: Reducing Acute Kidney Injury (REDUCE-AKI) was a single-centre, prospective, randomized, double-blind sham-controlled clinical trial, designed to examine the effect of an automated matched saline infusion with urine output for the prevention of AKI in patients undergoing TAVI. A total of 136 TAVI patients were randomized, 68 in each group. Mean age was 83.9 ± 5 years and 41.2% were males. There were no differences in baseline characteristics between the two groups. The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408). There was a significant increase in long-term mortality in the active group (27.9% vs. 13. 2% HR 3.744, 95% CI 1.51-9.28; P = 0.004). The study was terminated prematurely by the Data Safety Monitoring Board for futility and a possible signal of harm., Conclusions: Unlike in PCI, forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI, and might be associated with increased long-term mortality. Future studies should focus on understanding the mechanisms behind these findings., Clinicaltrials.gov Registration: NCT01866800, 30 April 2013., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2019
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