Research Article| Volume 166, ISSUE 2, P482-486, June 20, 2013

Download started.


Feasibility study of the RenalGuard™ balanced hydration system: A novel strategy for the prevention of contrast-induced nephropathy in high risk patients

Published:December 29, 2011DOI:



      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.


      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.


      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.


      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.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to International Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Rihal C.S.
        • Textor S.C.
        • Grill D.E.
        • Berger P.B.
        • Ting H.H.
        • Best P.J.
        • Singh M.
        • Bell M.R.
        • Barsness G.W.
        • Mathew V.
        • Garratt K.N.
        • Holmes Jr., D.R.
        Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention.
        Circulation. 2002; 105: 2259-2264
        • Mueller C.
        • Seidensticker P.
        • Buettner H.J.
        • Perruchoud A.P.
        • Staub D.
        • Christ A.
        • Buerkle G.
        Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral volume supplementation.
        Swiss Med Wkly. 2005; 135: 286-290
        • Hou S.H.
        • Bushinsky D.A.
        • Wish J.B.
        • Cohen J.J.
        • Harrington J.T.
        Hospital-acquired renal insufficiency: a prospective study.
        Am J Med. 1983; 74: 243-248
        • McCullough P.A.
        • Wolyn R.
        • Rocher L.L.
        • Levin R.N.
        • O'Neill W.W.
        Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality.
        Am J Med. 1997; 103: 368-375
        • McCullough P.A.
        Contrast-induced acute kidney injury.
        J Am Coll Cardiol. Apr. 15 2008; 51: 1419-1428
        • El-Hajjar M.
        • Bashir I.
        • Khan M.
        • Min J.
        • Torosoff M.
        • DeLago A.
        Incidence of contrast-induced nephropathy in patients with chronic renal insufficiency undergoing multidetector computed tomographic angiography treated with preventive measures.
        Am J Cardiol. Aug. 1 2008; 102 (Epub 2008 May 29): 353-356
        • Kelly A.M.
        • Dwamena B.
        • Cronin P.
        • Bernstein S.J.
        • Carlos R.C.
        Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy.
        Ann Intern Med. 2008; 148: 284-294
        • Gonzales D.A.
        • Norsworthy K.J.
        • Kern S.J.
        • Banks S.
        • Sieving P.C.
        • Star R.A.
        • Natanson C.
        • Danner R.L.
        A meta-analysis of N-acetylcysteine in contrast-induced nephrotoxicity: unsupervised clustering to resolve heterogeneity.
        BMC Med. 2007; : 32
        • Hoffmann U.
        • Fischereder M.
        • Kru¨ger B.
        • Drobnik W.
        • Kra¨mer B.K.
        The value of N-acetylcysteine in the prevention of radiocontrast agent-induced nephropathy seems questionable.
        J Am Soc Nephrol. 2004; 15: 407-410
        • Iyisoy A.
        • Celik T.
        • Yuksel U.C.
        • Bugan B.
        • Isik E.
        The value of hydration and acetylcysteine in the prevention of contrast-induced nephropathy: a potentially catastrophic complication of the percutaneous coronary interventions.
        Int J Cardiol. May 21 2008;
        • Brar S.S.
        • Shen A.Y.
        • Jorgensen M.B.
        • Kotlewski A.
        • Aharonian V.J.
        • Desai N.
        • Ree M.
        • Shah A.I.
        • Burchette R.J.
        Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial.
        JAMA. Sep. 3 2008; 300: 1038-1046
        • Trivedi H.S.
        • Moore H.
        • Nasr S.
        • Aggarwal K.
        • Agrawal A.
        • Goel P.
        • Hewett J.
        A randomized prospective trial to assess the role of saline hydration on the development of contrast nephrotoxicity.
        Nephron Clin Pract. 2003; 93: C29-C34
        • Mueller C.
        • Buerkle G.
        • Buettner H.J.
        • Petersen J.
        • Perruchoud A.P.
        • Eriksson U.
        • Marsch S.
        • Roskamm H.
        Prevention of contrast media-associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty.
        Arch Intern Med. Feb. 11 2002; 162: 329-336
        • Solomon R.
        • Werner C.
        • D'Elia J.
        • Mann D.
        Effects of saline, mannitol, and furosemide to prevent acute decreases in renal function induced by radiocontrast agents.
        N Engl J Med. 1994; 331: 1416-1420
        • Stevens M.
        • McCullough P.
        • Tobin K.
        • Speck J.P.
        • Westveer D.C.
        • Guido-Allen D.A.
        • Timmis G.C.
        • O'Neill W.W.
        A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy.
        J Am Coll Cardiol. 1999; 33: 403-411
        • Levin H.R.
        • Baran D.A.
        • Gelfand G.
        Forced diuresis with matched maintenance of intravascular volume may prevent contrast induced nephropathy in post-transplant patients with moderate–severe baseline renal impairment.
        Cardiovasc Revasc Med. 2007; 8: 153
        • Levin H.R.
        • Gelfand M.
        • Wang J.
        Contrast-induced nephropathy is completely prevented by high volume diuresis with matched replacement of intravascular volume.
        Cardiovasc Revasc Med. 2007; 8: 123
        • Harjai K.J.
        • Raizada A.
        • Shenoy C.
        • Sattur S.
        • Orshaw P.
        • Yaeger K.
        • Boura J.
        • Aboufares A.
        • Sporn D.
        • Stapleton D.
        A comparison of contemporary definitions of contrast nephropathy in patients undergoing percutaneous coronary intervention and a proposal for a novel nephropathy grading system.
        Am J Cardiol. Mar. 15 2008; 101 (Epub 2008): 812-819
        • Dussol B.
        • Morange S.
        • Loundoun A.
        • Auquier P.
        • Berland Y.
        A randomized trial of saline hydration to prevent contrast nephropathy in chronic renal failure patients.
        Nephrol Dial Transplant. 2006; 21: 2120-2126
        • Majumdar S.R.
        • Kjellstrand C.M.
        • Tymchak W.J.
        • Hervas-Malo M.
        • Taylor D.A.
        • Teo K.K.
        Forced euvolemic diuresis with mannitol and furosemide for prevention of contrast-induced nephropathy in patients with CKD undergoing coronary angiography: a randomized controlled trial.
        Am J Kidney Dis. 2009; 54: 602-609
        • Rudnick M.R.
        • Davidson C.
        • Laskey W.
        • Stafford J.L.
        • Sherwin P.F.
        VALOR trial investigators.
        Am Heart J. Oct. 2008; 156: 776-782
        • Lee S.W.
        • Kim W.J.
        • Kim Y.H.
        • Park S.W.
        • Park D.W.
        • Yun S.C.
        • Lee J.Y.
        • Kang S.J.
        • Lee C.W.
        • Lee J.H.
        • Choi S.W.
        • Seong I.W.
        • Suh J.
        • Cho Y.H.
        • Lee N.H.
        • Cheong S.S.
        • Yoo S.Y.
        • Lee B.K.
        • Lee S.G.
        • Hyon M.S.
        • Shin W.Y.
        • Lee S.W.
        • Jang J.S.
        • Park S.J.
        Preventive strategies of renal insufficiency in patients with diabetes undergoing intervention or arteriography (PREVENT) trial.
        Am J Cardiol. 2011;
      1. Berwanger O. AHA 2010. LBCT III: Abstract 21843. Acetylcysteine for the prevention of contrast-induced nephropathy (ACT) trial: a pragmatic multicenter randomized trial to evaluate the efficacy of Acetylcysteine for the prevention of renal outcomes in patients undergoing coronary and vascular angiography. Circulation Vol 122, No 21 November 23, 2010.

        • Schultz M.J.
        • Baas M.C.
        • van der Sluijs H.P.
        • Stamkot G.A.
        • Smit W.
        N-acetylcysteine and other preventive measures for contrast-induced nephropathy in the intensive care unit.
        Curr Med Chem. 2006; 13: 2565-2570
        • Mehran R.
        • Aymong E.D.
        • Nikolsky E.
        • Lasic Z.
        • Iakovou I.
        • Fahy M.
        • Mintz G.S.
        • Lansky A.J.
        • Moses J.W.
        • Stone G.W.
        • Leon M.B.
        • Dangas G.
        A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation.
        J Am Coll Cardiol. Oct. 6 2004; 44: 1393-1399
        • Briguori C.
        • Visconti G.
        • Focaccio A.
        • Airoldi F.
        • Valgimigli M.
        • Sangiorgi G.M.
        • Golia B.
        • Ricciardelli B.
        • Condorelli G.
        REMEDIAL II Investigators. Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.
        Circulation. 2011 Sep 13; 124: 1260-1269