AKIGUARD (Acute Kidney Injury GUARding Device) trial

Usmiani, Tullio; Andreis, Alessandro; Budano, Carlo; Sbarra, Pierluigi; Andriani, Monica; Garrone, Paolo; Fanelli, Antonella; Calcagnile, Chiara; Bergamasco, Laura; Biancone, Luigi; Marra, Sebastiano

doi:10.2459/jcm.0000000000000348

Cited by 32 publications

(22 citation statements)

References 29 publications

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“…Three RCTs that included 586 patients met the inclusion criteria . The search flow diagram is shown in the Supporting Information, Figure S1, in the online version of this article.…”

Section: Resultsmentioning

confidence: 99%

“…It showed the safety of this device in 23 patients . Since then, several RCTs and prospective studies have shown its efficacy in patients with CKD undergoing diagnostic coronary angiography as well as coronary intervention . Recently, the RenalGuard system has also been shown to be effective in preventing kidney injury in high‐risk patients undergoing transcatheter aortic valve replacement (TAVR) .…”

Section: Discussionmentioning

confidence: 99%

“…23 Since then, several RCTs and prospective studies have shown its efficacy in patients with CKD undergoing diagnostic coronary angiography as well as coronary intervention. [6][7][8][9] Recently, the RenalGuard system has also been shown to be effective in preventing kidney injury in high-risk patients undergoing transcatheter aortic valve replacement In a study by Chorin, 150 patients undergoing coronary angiography, angioplasty, or TAVR who were considered to be at high risk for CIN received forced diuresis with matched hydration and exhibited a significant decrease in their incidence of AKI. 25 In addition, Briguori and colleagues, using the RenalGuard system, demonstrated that a mean intraprocedural urine flow rate of ≥450 mL/h is effective at preventing AKI in high-risk patients.…”

Section: Discussionmentioning

confidence: 99%

“…Three RCTs that included 586 patients met the inclusion criteria. [7][8][9] The search flow diagram is shown in the Supporting Information, Figure S1, in the online version of this article. The bias assessment for each RCT is shown in the Supporting Information, Figure S2, in the online version of this article.…”

Section: Study Selection and Patient Populationmentioning

confidence: 99%

“…Recently, several small randomized controlled trials (RCTs) and prospective studies have shown that in patients with chronic kidney disease (CKD), furosemide-induced high-volume forced diuresis with matched hydration using the RenalGuard system (RenalGuard Solutions, Inc., Milford, MA) can prevent CIN. [6][7][8][9] However, some critiques are skeptical of these findings; they describe the results as simple changes in biomarker (creatinine) levels because individual studies do not have enough power to show significant differences in hard clinical endpoints such as renal replacement therapy (RRT) or major adverse clinical events (MACEs). 10 This prompted us to perform a comprehensive meta-analysis of the RCTs.…”

Section: Introductionmentioning

confidence: 99%

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High‐volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast‐induced nephropathy: A meta‐analysis of randomized trials

Shah

Wood

Khan

et al. 2017

Clinical Cardiology

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Background Contrast‐induced nephropathy (CIN) is a well‐recognized complication of coronary angiography that is associated with poor outcomes. Several small randomized controlled trials (RCTs) have recently shown that in patients with chronic kidney disease (CKD), furosemide‐induced forced diuresis with matched hydration using the RenalGuard system can prevent its occurrence. However, individual studies have been underpowered and thus cannot show significant differences in major clinical endpoints. Hypothesis Forced diuresis with matched hydration using the RenalGuard system improves clinical outcomes in patients undergoing coronary angiography. Methods Scientific databases and websites were searched for relevant RCTs. The pooled risk ratios were calculated using random‐effects models. The primary endpoint was CIN, and the secondary endpoints were major adverse clinical events (MACEs) and the need for renal replacement therapy. Results Data from 3 trials including 586 patients were analyzed. High‐volume forced diuresis with matched hydration using the RenalGuard system decreased risk of CIN by 60% (risk ratio: 0.40, 95% confidence interval: 0.25 to 0.65, P < 0.001), MACE rate by 59%, and the need for renal replacement therapy by 78%, compared with the standard of care. Conclusions In patients with CKD undergoing coronary angiography, high‐volume forced diuresis with matched hydration using the RenalGuard system significantly reduces the risk of CIN, MACE rate, and the need for renal replacement therapy. Larger RCTs with sufficient power are needed to confirm these findings.

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“…Three RCTs that included 586 patients met the inclusion criteria . The search flow diagram is shown in the Supporting Information, Figure S1, in the online version of this article.…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Study Selection and Patient Populationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

High‐volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast‐induced nephropathy: A meta‐analysis of randomized trials

Shah

Wood

Khan

et al. 2017

Clinical Cardiology

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Renal insufficiency following contrast media administration trial III: Urine flow rate‐guided versus left‐ventricular end‐diastolic pressure‐guided hydration in high‐risk patients for contrast‐induced acute kidney injury. Rationale and design

Briguori

D’Amore

Micco

et al. 2019

Cathet Cardio Intervent

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Background: Urine flow rate (UFR)-guided and left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigatorsponsored trial aiming to compare these two hydration strategies.Methods: Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m 2 and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group). Seven-hundred patients (350 in each arm) will be enrolled. In the LVEDP-guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg −1 hr −1 for LVEDP ≤12 mmHg, 3 mL kg −1 hr −1 for LVEDP 13-18 mmHg, and 1.5 mL kg −1 hr −1 for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low-osmolar, nonionic contrast agent) will be administered. Results:The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema. Conclusion:The REMEDIAL III will test the hypothesis that the UFR-guided hydration is superior to the LVEDP-guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema. K E Y W O R D S

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Forced Matched Diuresis: Role in Renal Protection in the Cardiac Catheterization Laboratory

Solomon

Narasimhadevara

2020

Kidney Disease in the Cardiac Catheterization Laboratory

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AKIGUARD (Acute Kidney Injury GUARding Device) trial

Abstract: Matched hydration was more effective than BS-NAC in CIAKI prevention. One-year follow-up showed that matched hydration was associated also with limited chronic kidney disease progression, major adverse cardiac and cerebrovascular events and hospitalizations.

Cited by 32 publications

References 29 publications

High‐volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast‐induced nephropathy: A meta‐analysis of randomized trials

High‐volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast‐induced nephropathy: A meta‐analysis of randomized trials

Renal insufficiency following contrast media administration trial III: Urine flow rate‐guided versus left‐ventricular end‐diastolic pressure‐guided hydration in high‐risk patients for contrast‐induced acute kidney injury. Rationale and design

Forced Matched Diuresis: Role in Renal Protection in the Cardiac Catheterization Laboratory

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