Reducing Acute Kidney Injury - REDUCE-AKI
Contribution To Literature:
The REDUCE-AKI trial failed to show that forced diuresis was superior to control at preventing acute kidney injury after TAVR.
Description:
The goal of the trial was to evaluate forced diuresis compared with control among patients with renal insufficiency undergoing transfemoral transcatheter aortic valve replacement (TAVR).
Study Design
- Randomized
- Parallel
- Double-blind
- Sham-control
Patients undergoing transfemoral TAVR were randomized to forced diuresis (n = 68) versus sham (n = 68). All patients received isotonic saline infusion (0.5-1 ml/kg/h, 12 hours prior to the procedure) and Foley catheter placement.
In the forced diuresis group, in the preoperative area, patients received an additional intravenous bolus of normal saline 250 cc and intravenous furosemide 0.25-0.5 mg/kg. TAVR was commenced when urine output exceeded 300 cc/h. Hydration was continued for up to 6 hours after the procedure at the same rate as the urine output.
In the sham group, patients received hydration at a rate of 0.5-1 ml/kg/h during and up to 6 hours after the procedure.
Inclusion criteria:
- Patients ≥65 years of age undergoing transfemoral TAVR
- Renal insufficiency (estimated glomerular filtration rate [eGFR] ≤60 cc/min/1.73 m2)
Exclusion criteria:
- Acute coronary syndrome in the last 30 days
- History of congestive heart failure with left ventricular ejection fraction <30%
- On renal dialysis
- Furosemide hypersensitivity
- Contraindication to Foley catheter placement
Other salient features/characteristics:
- Total urine output 6 hours after the procedure: 3682 cc in the forced diuresis group vs. 1200 cc in the control group (p < 0.001)
Principal Findings:
The primary outcome, incidence of acute kidney injury, occurred in 25% of the forced diuresis group compared with 19% of the control group (p = 0.41).
The secondary outcome, long-term mortality, occurred in 27.9% of the forced diuresis group compared with 13.2% of the control group (p = 0.004).
Interpretation:
Among patients undergoing TAVR, forced diuresis was not superior to sham control at preventing acute kidney injury. The trial was terminated early due to futility and also a signal for possible harm. The mechanism for possible harm from forced diuresis is not known. This study suggests that contrast dye may have a negligible role in the development of acute kidney injury.
References:
Arbel Y, Ben-Assa E, Puzhevsky D, et al. Forced Diuresis With Matched Hydration During Transcatheter Aortic Valve Implantation for Reducing Acute Kidney Injury: A Randomized, Sham-Controlled Study (REDUCE-AKI). Eur Heart J 2019;40:3169-78.
Editorial: Koyner J, Bakris G. Kidney Injury Is Not Prevented by Hydration Alone. Eur Heart J 2019;40:3179-81.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Statins, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Acute Kidney Injury, Catheters, Diuresis, Furosemide, Glomerular Filtration Rate, Heart Failure, Heart Valve Diseases, Medical Futility, Renal Dialysis, Transcatheter Aortic Valve Replacement
< Back to Listings