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- Title
Effect of an Oral Shiga Toxin–Binding Agent on Diarrhea-Associated Hemolytic Uremic Syndrome in Children: A Randomized Controlled Trial.
- Authors
Trachtman, Howard; Cnaan, Avital; Christen, Erica; Gibbs, Kathleen; Zhao, Sanyi; Acheson, David W. K.; Weiss, Robert; Kaskel, Frederick J.; Spitzer, Adrian; Hirschman, Gladys H.
- Abstract
Context: Diarrhea-associated hemolytic uremic syndrome (HUS) is the most common cause of acute renal failure in children. Most cases are caused by an intestinal infection with Shiga toxin–producing strains of Escherichia coli. Objective: To determine if administration of an oral agent that binds Shiga toxin could diminish the severity of diarrhea-associated HUS in pediatric patients. Design, Setting, and Patients: Multicenter, randomized, double-blind, placebo-controlled clinical trial of 145 children (96 experimental and 49 placebo) aged 6 months to 18 years with diarrhea-associated HUS conducted between July 27, 1997, and April 14, 2001, at 26 tertiary care pediatric nephrology centers in the United States and Canada. Trial included 2 phases, the hospital course for treatment of the acute illness and a 60-day outpatient follow-up period after discharge from the hospital. Intervention: Patients were assigned to receive the binding agent, 500 mg/kg daily, or cornmeal placebo orally for 7 days in a 2:1 randomization scheme. Main Outcome Measures: Combined frequency of death or serious extrarenal events and need for dialysis in the experimental vs placebo group. Results: A total of 62 patients (43%) were male and 123 (85%) were white. The median age of the patients was 4.2 years. Most patients (59%) were transferred from other hospitals to participating sites. The severity of disease at the time of randomization was comparable in the 2 groups. The prevalence of death or serious extrarenal events was 18% and 20% in the experimental and placebo groups, respectively (P = .82). Dialysis was required in 42% of experimental and 39% of placebo groups (P = .86). Conclusions: Oral therapy with a Shiga toxin–binding agent failed to diminish the severity of disease in pediatric patients with diarrhea-associated HUS.
- Subjects
DIARRHEA; HEMOLYTIC-uremic syndrome; PLACEBOS; JUVENILE diseases
- Publication
JAMA: Journal of the American Medical Association, 2003, Vol 290, Issue 10, p1337
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.290.10.1337