Randomized controlled trial to compare the tolerability and efficacy of treatment with Icodextrin 7.5% versus Dextrose 2.5% in chronic peritoneal dialysis patients with high/high average solute transport characteristics and low residual renal function

Abstract

Aim: Comparison of tolerability and efficacy of treatment with icodextrin vs. dextrose 2.5% amongst high risk cohort of chronic peritoneal dialysis patients (high/high average solute transport characteristics and low residual renal function) over 3 months. Study Design and Methodology: The study was an open-label, comparative, prospective, randomized controlled trial, conducted at department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. A total of 349 end stage renal disease patients on chronic peritoneal dialysis were screened for eligibility over a period of 6 months and 41 patients with high / high average solute transport characteristics and low residual renal function were randomized to receive either icodextrin 7.5% solution or 2.5% dextrose solution in long dwell. Patients were assessed for adequacy of peritoneal dialysis (creatinine & urea clearance), peritoneal membrane transport characteristics including solute clearance (standard peritoneal equilibration test), body composition, total body water, fat mass and fat free mass (using whole body tetrapolar bioimpedance analyzer) at baseline and at the end of 3 months. Statistical Analysis: Continuous variables were compared with independent samples paired t test if normally distributed, or with Mann–Whitney U test if the distribution was skewed. Categorical variables were analyzed with Chi-square test or Fisher exact test as appropriate. Pearson's correlation coefficient was calculated between different quantitative variables. Paired t test and Wilcoxon signed-rank test were used for within-group comparisons. Repeated measure ANOVA was used to compare bioelectrical impedance between intervention groups. Results: The study has shown that use of icodextrin based continuous ambulatory peritoneal dialysis resulted in better ultrafiltration and improved solute clearance when compared to 2.5% dextrose based peritoneal dialysis in a select cohort of patients having high/high average transporter characteristics with poor residual renal function, however, it didn't significantly alter total body water and failed to translate into improvements in either patient's or physician's assessment of global health of response to therapy atleast at 3 months. Conclusions: Although use of icodextrin based peritoneal dialysis solution for long dwell resulted in significant improvement in solute clearance and ultrafiltration nevertheless failed to translate into better hydration status or subjective improvement scores atleast at 3 months.