Abstract
Background
Contrast-induced nephropathy (CIN) is a frequent complication following angiographic
procedures with significant impact on healthcare costs, and long-term outcomes. Multiple
reno-protective strategies have been studied but few have shown benefit in prospective
randomized studies beyond limiting the exposure to iodinated contrast and adequate
intravenous. We studied the performance and safety of a novel system designed to achieve
precise real-time high volume fluid balance using a closed loop hydration monitoring
and infusion system.
Methods
This prospective, multi-center, FDA approved phase II feasibility study was designed
to evaluate the safety and the performance of the RenalGuard matched hydration system.
Between October 2006 and November 2007, twenty-three subjects at high risk for CIN
(with an estimated glomerular filtration rate (eGFR)<50 ml/min/1.73 m2) undergoing diagnostic or therapeutic catheterization were treated with the system.
The primary endpoint of the study was defined as the ability of the system to effectively
dynamically match fluid administration to urine output.
Results
The 23 subjects at high risk for CIN enrolled had a mean±SD eGFR of 39±9.3. Patients achieved an hourly urine flow rate of 620±400 ml/h. The system had a mean effectiveness rate of 99.9% over the duration of therapy
with an average saline volume infused of 3825 ml closely matched, minute to minute, to urine output of 3579 ml. There were no major device-related complications from the experimental therapy,
though one patient developed hypokalemia requiring replacement. Two subjects (9.5%)
developed CIN as defined by >0.5 mg/dl or >25% rise in serum creatinine at 48–60 h post contrast administration when compared with the baseline.
Conclusion
The study confirmed that the RenalGuardTM system is safe and dynamically balances volume hydration with urine production. Further
randomized studies are needed to confirm the efficacy of the system in reducing the
incidence of CIN.
Keywords
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Article info
Publication history
Published online: December 29, 2011
Accepted:
November 24,
2011
Received in revised form:
October 22,
2011
Received:
May 15,
2011
Footnotes
☆This study was supported, in part, by a clinical research grant from PLC Medical, Inc.
Identification
Copyright
© 2011 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
