title: Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.
abstract: BACKGROUND
  The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury.
  
  
  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.
  
  
  CONCLUSIONS
  RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.
  
  
  BACKGROUND
  URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032.
authors.affiliation: Laboratory of Interventional Cardiology, 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: Amelia
authors.initials: A
authors.lastname: Focaccio
authors.forename: Flavio
authors.initials: F
authors.lastname: Airoldi
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Giuseppe Massimo
authors.initials: GM
authors.lastname: Sangiorgi
authors.forename: Bruno
authors.initials: B
authors.lastname: Golia
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* / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D002254:Carbonates / Q000008:administration & dosage*; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D005665:Furosemide / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D051437:Renal Insufficiency / Q000139:chemically induced / Q000517:prevention & control; D012307:Risk Factors; D012965:Sodium Chloride / Q000008:administration & dosage*
chemical_list: D002254:Carbonates; D003287:Contrast Media; D012965:Sodium Chloride; C005686:sodium carbonate; D005665:Furosemide; D000111:Acetylcysteine