title: Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).
abstract: OBJECTIVE
  To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.
  
  
  METHODS
  Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up.
  
  
  RESULTS
  Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Δ = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted.
  
  
  CONCLUSIONS
  Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD.
  
  
  CONCLUSIONS
  • Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI. • Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease. • Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients. • No case or sign of NSF was detected at 3-month follow-up.
authors.affiliation: Department of Nephrology, Pitié Salpétrière Hospital, Bat G. Cordier, 47-83 Bd de l'hôpital, 75651 Paris cedex 13, France. gilbert.deray@psl.ap-hop-paris.fr
authors.forename: Gilbert
authors.initials: G
authors.lastname: Deray
authors.forename: Olivier
authors.initials: O
authors.lastname: Rouviere
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Bacigalupo
authors.forename: Bart
authors.initials: B
authors.lastname: Maes
authors.forename: Thierry
authors.initials: T
authors.lastname: Hannedouche
authors.forename: François
authors.initials: F
authors.lastname: Vrtovsnik
authors.forename: Claire
authors.initials: C
authors.lastname: Rigothier
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Billiouw
authors.forename: Paolo
authors.initials: P
authors.lastname: Campioni
authors.forename: Joaquin
authors.initials: J
authors.lastname: Ferreiros
authors.forename: Daniel
authors.initials: D
authors.lastname: Devos
authors.forename: Daniel
authors.initials: D
authors.lastname: Alison
authors.forename: François
authors.initials: F
authors.lastname: Glowacki
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Boffa
authors.forename: Luis
authors.initials: L
authors.lastname: Marti-Bonmati
mesh_terms: D058186:Acute Kidney Injury / Q000453:epidemiology*; D000368:Aged; D003287:Contrast Media; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006571:Heterocyclic Compounds; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D054989:Nephrogenic Fibrosing Dermopathy / Q000453:epidemiology*; D009942:Organometallic Compounds; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis* / Q000453:epidemiology*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C050823:gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate