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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EInvestigators from the Renal Insufficiency Following Contrast Media Administration Trial II [REMEDIAL II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01098032\u0026amp;atom=%2Fspmdc%2F11%2F3%2F22.2.atom\u0022\u003ENCT01098032\u003C\/a\u003E] report that the RenalGuard\u2122 automated hydration matching system is safe and effective in preventing contrast-induced acute kidney injury in high- and very-high-risk patients with chronic kidney disease compared with the optimal strategy of sodium bicarbonate infusion plus N-acetylcysteine.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Insufficiency\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EInvestigators from the Renal Insufficiency Following Contrast Media Administration Trial II (REMEDIAL II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01098032\u0026amp;atom=%2Fspmdc%2F11%2F3%2F22.2.atom\u0022\u003ENCT01098032\u003C\/a\u003E) report that the RenalGuard\u2122 automated hydration matching system is safe and effective in preventing contrast-induced acute kidney injury (CI-AKI) in high- and very-high-risk patients with chronic kidney disease (CKD) compared with the optimal strategy of sodium bicarbonate infusion plus N-acetylcysteine (NAC). Carlo Brigouri, MD, PhD, Clinica Mediterranea, Naples, Italy, presented the findings.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EContrast-induced acute kidney injury is strongly associated with unfavorable early and late clinical outcomes in patients, which may be mitigated by maintaining a high urine flow. Prior strategies focused on forced diuretic regimens (typically with high-dose furosemide), which may be harmful due to a resulting negative fluid balance. The primary hypothesis of REMEDIAL II was that achieving a precise real-time high urine output and matched fluid balance using the RenalGuard\u2122 hydration system would be noninferior to a control hydration strategy of prophylactic sodium bicarbonate plus NAC to prevent CI-AKI.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EREMEDIAL II was a multicenter, prospective trial that included of 294 patients at elevated risk of contrast nephropathy, randomized to either hydration by the RenalGuard\u2122 system (n=135; hydration with normal saline [target urine flow \u2265300 ml\/h]+1.5 g\/L NAC+ 0.25 mg\/kg furosemide) or hydration with sodium bicarbonate and acetylcysteine (n=145; hydration by 3 ml\/kg of IV sodium bicarbonate for 1 hour before treatment and 1 ml\/kg for 6 hours after, and 1200 mg NAC bid x 2 and 1.5 g during therapy). In all cases, the contrast media that was administered was iodixanol (an iso-osmolar, nonionic contrast agent).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary endpoint was the rate of CI-AKI, defined as an increase of \u22650.3 mg\/dL in serum creatinine (sCr) concentration 48 hours after the procedure. Secondary endpoints included an increase in the sCr concentration \u226525% and \u22650.5 mg\/dL at 48 hours after contrast exposure; changes in serum cystatin C (sCyC) concentration at 24 and 48 hours after contrast exposure; the rate of acute renal failure that required dialysis; the rate of in-hospital and 1-month major adverse events (composite of death, renal failure requiring dialysis, or acute pulmonary edema); and changes in serum and urine NGAL concentrations at 2, 6, 12, 24, and 48 hours postcontrast exposure.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe mean age of the 294 patients was 75 years, about one-third were women, almost all had hypertension, 70% had diabetes, half were on an ACE inhibitor, and the mean eGFR was 32 ml\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E. The mean volume of contrast that was infused was about 135\u2013140 ml.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe percentage primary endpoint occurred in 11% in the RenalGuard\u2122 group and 20.5% in the control group (OR, 0.47; 95% CI, 0.24 to 0.92; p=0.025; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). This translated into an absolute risk difference of 8.5%, or a number needed to treat of 12 to prevent 1 patient with a 10% rise in creatinine after contrast exposure. The secondary endpoint of an increase in the sCr concentration \u226525% at 48 hours after contrast exposure occurred in 2.7% in the RenalGuard\u2122 group and 13% in the control group (p=0.001). Similarly, changes in creatinine and cystatin C at 48 hours (secondary endpoints) were significantly reduced (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E) in the RenalGuard\u2122 group. At 1 month, 0.7% of patients in the RenalGuard\u2122 group versus 4.8% in the control group needed dialysis (number needed to treat of 25 to prevent 1 patient requiring dialysis; p=0.031). The cumulative secondary endpoint of major adverse events occurred in 6.8% in the RenalGuard\u2122 group compared with 9.6% in the control group (p=0.52)\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/12261\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/12261\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12261\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ESecondary Endpoints.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/3\/22.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Endpoint.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-30275235\u0022 data-figure-caption=\u0022Primary Endpoint.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/3\/22.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/3\/22.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/3\/22.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12260\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EPrimary Endpoint.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ECI-AKI=Contrast-Induced Acute Kidney Failure\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EData from REMEDIAL II demonstrate that among patients who are at high risk for contrast nephropathy, the aggressive hydration and matched fluid balanced that were achieved with the RenalGuard\u2122 system (in conjunction with NAC and furosemide) were superior to hydration with sodium bicarbonate plus NAC in preventing contrast-induced sCr increases. Future trials should determine whether the automated closed-loop system that balances fluid management could be replicated simply with a routine aggressive hydration strategy.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/3\/22.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzn3g1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn3g1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzn3g1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}