A Randomized Multicenter Clinical Trial to Evaluate the Effects of An Ultraviolet Germicidal System on Peritonitis Rate in Continuous Ambulatory Peritoneal Dialysis

Abstract

In continuous ambulatory peritoneal dialysis (CAPD), peritonitis frequently is assumed to result from spike contamination during bag exchanges. An ultraviolet germicidal chamber has been developed, which disinfects the spike and the solution-bag outlet before spike insertion. This report summarizes the results of a multicenter trial carried out to determine if this device reduces the incidence of peritonitis in patients on CAPD. Ten centers contributed 167 patients who were followed during a base-line historical control period for a minimum of four months. Thereafter, 93 patients were randomized to a control group, and 74 to the test group. After an interim period for retraining (both groups) and change over (test group), a trial period of nine months was undertaken. Peritonitis rates and actuarial analyses of time-to-peritonitis showed no significant differences between historical and trial periods in either group, or between groups during either period. In both groups, rates of peritonitis were consistently lower than rates reported in the National Registry. The results suggest that, in the patients participating in these studies, spike contamination may have been an infrequent cause of peritonitis. In the U.S.A. over 9000 patients with end-stage renal disease are maintained on continuous ambulatory peritoneal dialysis (CAPD) (I). A peritonitis rate of 1.6 episodes per patient year represents the national average in the latest report of the U.S.A. CAPD Registry (2). Most clinicians assume that spike contaminations during bag exchanges are responsible for some portion of these episodes. Popovich, Moncrief and colleagues have described preliminary experiences with an ultraviolet germicidal system shown to disinfect intraspike contaminations with solutions containing 200,000 organisms per ml (3–4). An integrated dose of ultraviolet light within the germicidal chamber kills microorganisms before spike insertion into a fresh bag of solution. An improved chamber has been made available for clinical trials by Travenol Laboratories Inc (Deerfield, Illinois) (5). This study summarizes the results of a multicenter trial designed to test the effects of this germicidal chamber on the frequency of peritonitis in a population of patients maintained on CAPD.