title: Long-term follow-up of patients randomized to biocompatible or conventional peritoneal dialysis solutions show no difference in peritonitis or technique survival.
abstract: Peritonitis remains a common clinical problem for patients on peritoneal dialysis (PD). There are, however, retrospective studies with historical controls that suggest that biocompatible PD solutions may reduce the rates of peritonitis. We conducted a randomized controlled study comparing the use of biocompatible and conventional solutions, accumulating over 7000 patient-months experience. We included peritonitis episodes from patients who discontinued PD during the follow-up period. The study was powered to detect a reduction in the peritonitis rate of over half in the 267 randomized patients in demographically similar groups. There were no intergroup differences in PD technique survival irrespective of whether the outcome was censored for death. Peritonitis-free survival was 26.7 months using conventional compared to 23.1 months using biocompatible PD solutions. The peritonitis rates were also not statistically different when measured in patient-months. Thus, despite the finding of non-randomized studies suggesting benefits of the biocompatible PD solutions, we could not detect any clinically significant advantages in terms of technique survival or peritonitis. Although our study is the largest randomized study comparing different PD solutions to date, we do not exclude the possibility that our results are a consequence of the lack of statistical power. Meta-analysis of randomized control trials in this field is essential.
authors.affiliation: Renal Unit, Department of Renal Medicine and Transplantation, The Royal London and St Bartholomew's Hospitals, London, UK.
authors.forename: Shalabh
authors.initials: S
authors.lastname: Srivastava
authors.affiliation: Renal Unit, Department of Renal Medicine and Transplantation, The Royal London and St Bartholomew's Hospitals, London, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hildebrand
authors.affiliation: Renal Unit, Department of Renal Medicine and Transplantation, The Royal London and St Bartholomew's Hospitals, London, UK. Electronic address: s.fan@qmul.ac.uk.
authors.forename: Stanley L-S
authors.initials: SL
authors.lastname: Fan
mesh_terms: D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D015314:Dialysis Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy*; D008131:London; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D010538:Peritonitis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D006435:Renal Dialysis; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D015314:Dialysis Solutions