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.
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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)