Diarrhea-associated hemolytic uremic syndrome (HUS) is the most common cause of acute renal failure in children. Most cases of HUS are caused by intestinal infection with Shiga toxin-producing strains of Escherichia coli.
In this study, physicians from the United States investigated whether an oral agent which binds Shiga toxin could reduce the severity of diarrhea-associated HUS in pediatric patients.
The research team performed a multicenter, randomized, double-blind, placebo-controlled clinical trial. The study took place between 1997 and 2001 at 26 tertiary care pediatric nephrology centers in the United States and Canada.
The team included 145 children in the study. They were aged between 6 months and 18 years (median 4.2 years), and had diarrhea-associated HUS.
- experimental = 42%
- placebo = 39%
|Journal of the American Medical Association|
The trial included 2 phases. The first was hospital treatment of the acute illness, followed by a 60-day outpatient follow-up after discharge from hospital.
Patients were randomly assigned to receive either the binding agent (500 mg/kg daily) or a cornmeal placebo. The severity of disease at the time of randomization was similar between the 2 groups.
The team measured the combined frequency of death or serious extrarenal events, as well as the need for dialysis in each group.
The physicians found that most patients were transferred from other hospitals to participating sites.
They determined that the prevalence of death or serious extrarenal events in the experimental was 18%, compared to 20% in the placebo group.
Furthermore, they found that dialysis was required in 42% of experimental patients versus 39% of placebo patients.
Dr Howard Trachtman's team concluded, "Oral therapy with a Shiga toxin-binding agent failed to diminish the severity of disease in pediatric patients with diarrhea-associated HUS".