Document Detail


Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.
MedLine Citation:
PMID:  21844075     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2011-08-15
Journal Detail:
Title:  Circulation     Volume:  124     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-09-13     Completed Date:  2011-11-02     Revised Date:  2012-02-21    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1260-9     Citation Subset:  AIM; IM    
Affiliation:
Laboratory of Interventional Cardiology, Department of Cardiology, Clinica Mediterranea, Naples, Italy. carlobriguori@clinicamediterranea.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01098032
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MeSH Terms
Descriptor/Qualifier:
Acetylcysteine / 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:
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:
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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