title: Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial.
abstract: OBJECTIVE
  The main objectives of the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial were to evaluate the role of antimicrobial prophylaxis in the prevention of recurrent urinary tract infection (UTI) and renal scarring in children with vesicoureteral reflux (VUR). We present a comprehensive evaluation of renal scarring outcomes in RIVUR trial participants.
  
  
  METHODS
  This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2-71 months with grade 1-4 VUR diagnosed after a first or second febrile or symptomatic UTI. Study participants received trimethoprim-sulfamethoxazole or placebo and were followed for 2 years. Renal scarring was evaluated by baseline and follow-up (99m)technetium dimercaptosuccinic acid (DMSA) renal scans that were reviewed independently by two blinded reference radiologists.
  
  
  RESULTS
  At the end of the study, 58 (10%) of 599 children and 63 (5%) of 1197 renal units had renal scarring. New renal scarring did not differ between the prophylaxis and placebo groups (6% versus 7%, respectively). Children with renal scarring were significantly older (median age, 26 versus 11 months; P=0.01), had a second UTI before enrollment (odds ratio [OR], 2.85; 95% confidence interval [95% CI], 1.38 to 5.92), were more likely to be Hispanic (OR, 2.22; 95% CI, 1.13 to 4.34), and had higher grades of VUR (OR, 2.79; 95% CI, 1.56 to 5.0). The proportion of new scars in renal units with grade 4 VUR was significantly higher than in units with no VUR (OR, 24.2; 95% CI, 6.4 to 91.2).
  
  
  CONCLUSIONS
  Significantly more renal scarring was seen in relatively older children and in those with a second episode of febrile or symptomatic UTI before randomization. Preexisting and new renal scars occurred significantly more in renal units with grade 4 VUR than in those with low-grade or no VUR. Antimicrobial prophylaxis did not decrease the risk of renal scarring.
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material tmattoo@med.wayne.edu.
authors.forename: Tej K
authors.initials: TK
authors.lastname: Mattoo
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Russell W
authors.initials: RW
authors.lastname: Chesney
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Saul P
authors.initials: SP
authors.lastname: Greenfield
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Hoberman
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Ron
authors.initials: R
authors.lastname: Keren
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Ranjiv
authors.initials: R
authors.lastname: Mathews
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Lisa
authors.initials: L
authors.lastname: Gravens-Mueller
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Myra A
authors.initials: MA
authors.lastname: Carpenter
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Marva
authors.initials: M
authors.lastname: Moxey-Mims
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Massoud
authors.initials: M
authors.lastname: Majd
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Harvey A
authors.initials: HA
authors.lastname: Ziessman
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use; D002675:Child, Preschool; D002921:Cicatrix / Q000209:etiology*; D005260:Female; D006801:Humans; D007223:Infant; D007674:Kidney Diseases / Q000209:etiology*; D008297:Male; D012008:Recurrence; D014552:Urinary Tract Infections / Q000517:prevention & control; D014718:Vesico-Ureteral Reflux / Q000150:complications*
chemical_list: D000890:Anti-Infective Agents
keywords: anti-infective agents; child; humans; kidney; random allocation; reflux nephropathy; renal scarring; trimethoprim-sulfamethoxazole combination urinary tract infections; vesico-ureteral reflux