| Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury. | |
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MedLine Citation:
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PMID: 21844075 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury. METHODS AND RESULTS: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2) and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2): odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus -0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group. CONCLUSION: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032. |
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Authors:
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Carlo Briguori; Gabriella Visconti; Amelia Focaccio; Flavio Airoldi; Marco Valgimigli; Giuseppe Massimo Sangiorgi; Bruno Golia; Bruno Ricciardelli; Gerolama Condorelli; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial Date: 2011-08-15 |
Journal Detail:
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Title: Circulation Volume: 124 ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-09-13 Completed Date: 2011-11-02 Revised Date: 2012-02-21 |
Medline Journal Info:
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Nlm Unique ID: 0147763 Medline TA: Circulation Country: United States |
Other Details:
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Languages: eng Pagination: 1260-9 Citation Subset: AIM; IM |
Affiliation:
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Laboratory of Interventional Cardiology, Department of Cardiology, Clinica Mediterranea, Naples, Italy. carlobriguori@clinicamediterranea.it |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT01098032 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acetylcysteine
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administration & dosage* Acute Kidney Injury / chemically induced*, prevention & control* Aged Aged, 80 and over Carbonates / administration & dosage* Contrast Media / adverse effects* Female Fluid Therapy / methods Furosemide / administration & dosage* Humans Male Renal Insufficiency / chemically induced, prevention & control Risk Factors Sodium Chloride / administration & dosage* |
| Chemical | |
Reg. No./Substance:
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0/Carbonates; 0/Contrast Media; 497-19-8/sodium carbonate; 54-31-9/Furosemide; 616-91-1/Acetylcysteine; 7647-14-5/Sodium Chloride |
| Comments/Corrections | |
Comment In:
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Ann Intern Med. 2012 Jan 17;156(2):JC1-8, JC1-9
[PMID:
22250171
]
Circulation. 2011 Sep 13;124(11):1210-1 [PMID: 21911794 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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