Document Detail


Renal insufficiency following contrast media administration trial II (REMEDIAL II): RenalGuard system in high-risk patients for contrast-induced acute kidney injury: rationale and design.
MedLine Citation:
PMID:  21518686     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Aims: The combined prophylactic strategy of sodium bicarbonate plus N-acetylsyteine (NAC) seems to be effective in preventing contrast induced acute kidney injury (CI-AKI) in patients at low-to-medium risk. However, in patients at high and very high risk the rate of CI-AKI is still high. In this subset of patients the anticipated advantages of the RenalGuard(tm) System should be investigated. The RenalGuard(tm) System (PLC Medical Systems, Inc., Franklin, MA, USA) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard therapy, which is based on the theory that creating and maintaining a high urine output is beneficial by allowing a quick elimination of contrast media, and, therefore, reducing its toxic effects. Methods and results: The REMEDIAL II trial is a randomised, multicentre, investigator-sponsored trial addressing the hypothesis that the RenalGuard System is superior to the prophylaxis with sodium bicarbonate infusion plus NAC in preventing CI-AKI in high and very high risk patients. Consecutive patients with chronic kidney disease (CKD) and at high to very high risk for CI-AKI, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (control group) and 2) RenalGuard System treatment (RenalGuard group). All enrolled patients must have an estimated glomerular filtration rate ≤30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11. In all cases iodixanol (an iso-osmolar, non-ionic contrast agent) will be administered. The primary endpoint is an increase of ≥0.3 mg/dL in the serum creatinine concentration 48 hours after the procedure. Conclusions: The REMEDIAL II trial will give important answers on how to prevent CI-AKI in high and very high risk patients undergoing contrast media exposure.
Authors:
Carlo Briguori; Gabriella Visconti; Bruno Ricciardelli; Gerolama Condorelli
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  6     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-04-26     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  1117-22     Citation Subset:  IM    
Affiliation:
Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
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