title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy. carlobriguori@clinicamediterranea.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.forename: Gabriella
authors.initials: G
authors.lastname: Visconti
authors.forename: Bruno
authors.initials: B
authors.lastname: Ricciardelli
authors.forename: Gerolama
authors.initials: G
authors.lastname: Condorelli
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage; D058186:Acute Kidney Injury / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D002908:Chronic Disease; D003287:Contrast Media / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D004232:Diuretics / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D004867:Equipment Design; D005440:Fluid Therapy / Q000295:instrumentation*; D005665:Furosemide / Q000008:administration & dosage; D005919:Glomerular Filtration Rate; D006801:Humans; D007558:Italy; D007674:Kidney Diseases / Q000150:complications* / Q000503:physiopathology; D015641:Radiography, Interventional / Q000009:adverse effects*; D051437:Renal Insufficiency / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D017693:Sodium Bicarbonate / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
chemical_list: D015415:Biomarkers; D003287:Contrast Media; D004232:Diuretics; D014283:Triiodobenzoic Acids; D005665:Furosemide; D017693:Sodium Bicarbonate; D003404:Creatinine; C044834:iodixanol; D000111:Acetylcysteine