Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

Trials, Jul 2014

Background Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Methods/Design Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. Discussion The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. Trial registration Clinicaltrials.gov: NCT01866800, 30 April 30 2013.

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Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

Yaron Arbel 0 Eyal Ben-Assa 0 Amir Halkin Gad Keren Arie Lorin Schwartz Ofer Havakuk Eran Leshem-Rubinow Maayan Konigstein Arie Steinvil Yigal Abramowitz Ariel Finkelstein Shmuel Banai 0 Equal contributors Department of Cardiology, Tel-Aviv Medical Center affiliated to the Sackler Faculty of Medicine, Tel-Aviv University , 6 Weizman Street, Tel Aviv , Israel Background: Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Methods/Design: Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. Discussion: The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. - Background Acute kidney injury (AKI) is a frequent complication of coronary angiography, and is associated with unfavorable outcomes including major cardiovascular events, renal replacement therapy, prolonged hospitalization, and early death [1,2]. Recently, two randomized controlled trials have demonstrated that furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system (PLC Medical Systems, Milford, Massachusetts, USA) [3,4] reduces AKI in high-risk patients undergoing coronary procedures. Elderly patients undergoing TAVI have a high prevalence of chronic kidney disease (CKD) and therefore are at increased risk to develop AKI (Table 1). In recent reports, AKI has been observed in up to 41% of patients undergoing TAVI [5-11] and was associated with a four times higher post-procedural mortality [11-14]. RenalGuard is a Conformit Europenne (CE)-approved system that is being used worldwide. The objective of this randomized sham-controlled study is to assess the beneficial effect of treating TAVI patients with this system in reducing the occurrence of AKI. Methods/Design We describe a single-center, double-blinded, randomized sham-controlled trial that is being conducted at the Tel Aviv Medical Center, Tel Aviv, Israel. Transcatheter aortic valve implantation procedures All patients will undergo transfemoral aortic valve implantation per standard clinical practice. Briefly, the femoral artery will be accessed with the standard endovascular technique, thereafter the procedure involves advancing a large catheter (18 Fr) through the aortic arch, retrogradely Table 1 Definition of acute kidney injury post transcatheter aortic valve implantation (TAVI) according to the VARC-2 classification [15] Increase in serum creatinine to 150 to 199% of baseline Increase of 0.3 mg/dl (26.4 mmol/L) Urine output <0.5 ml/kg/h for >6 but <12 h Increase in serum creatinine to 200 to 299% of baseline Urine output <0.5 ml/kg/h for >2 but <24 h Increase in serum creatinine to 300% of baseline Exclusion criteria The exclusion criteria are as follows: OR Increase of serum creatinine of 4 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dl (44 mmol/l) Urine output <0.3 ml/kg/h for >24 h Anuria for >12 h crossing the aortic valve, following by balloon valvuloplasty and stent-valve implantation. During the procedure, the patients will receive analgesics and anxiolytics as per protocol. Post-procedural pharmacotherapy, sheath removal, and deployment of hemostatic devices will be left to the discretion of the attending cardiologists. Following treatment in the catheterization laboratory, medical treatment throughout hospitalization and follow-up treatment will be left to the discretion of the treating physician managing patient care on the hospital wards. Specific agents added or withdrawn will be made by treating physicians and will not be influenced by the study team. RenalGuard system The RenalGuard system (PLC Medical Systems, Milford, Massachusetts, USA) is a CE approved system that is being used worldwide. It includes a computer system that weighs the urine of the patient, calculates the urine rate (ml/min) and infuses matched IV normal saline into the patient, maintaining the initially programmed fluid balance. In our medical center, the RenalGuard system is routinely used for high-risk patients undergoing coronary procedures (Figure 1). Study population A total of 220 patients will be randomized. Eligible patients must be planned for elective TAVI and all must have an estimated glomerular filtrat (...truncated)


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Yaron Arbel, Eyal Ben-Assa, Amir Halkin, Gad Keren, Arie Schwartz, Ofer Havakuk, Eran Leshem-Rubinow, Maayan Konigstein, Arie Steinvil, Yigal Abramowitz, Ariel Finkelstein, Shmuel Banai. Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial, Trials, 2014, pp. 262, 15, DOI: 10.1186/1745-6215-15-262