Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH).

BACKGROUND: Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial. METHODS: This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days. RESULTS: Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195). CONCLUSIONS: The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.

Brazilian Peritoneal Dialysis Multicenter Study (BRAZPD): from conception to execution of a national peritoneal dialysis reality check.

Systematic data collection of patients undergoing renal replacement therapy is critical to the epidemiological and clinical understanding of the treatment. These data may allow more rational use of economic resources and identify interventions to improve treatment and decrease the morbidity and mortality of these patients. The Brazilian Peritoneal Dialysis Multicenter Study (BRAZPD), an observational cohort study of peritoneal dialysis (PD) patients in Brazil, aimed to collect monthly demographics, clinical, laboratory and outcome data of PD patients treated in 114 dialysis clinics around the country, was started in December 2004 and ended in September 2011. BRAZPD has been generating solid and important information, which is very useful as a reality check of the PD therapy for all Brazilian PD centers.

Family income and survival in Brazilian Peritoneal Dialysis Multicenter Study Patients (BRAZPD): time to revisit a myth?

BACKGROUND AND OBJECTIVES: Although low socioeconomic status has been considered a contraindication to peritoneal dialysis (PD), no published data clearly link it to poor outcomes. The goal of this study was assessing the effect of income on survival in the Brazilian Peritoneal Dialysis Multicenter STUDY. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Incident PD patients enrolled in this prospective cohort from December 2004 to October 2007 were divided according to monthly family income. The median age was 59 years, 54% were women, 60% Caucasians, 41% diabetics, and 24% had cardiovascular disease. Most of them were in continuous ambulatory PD, had not received predialysis care, had <4 school years, and had a family income of <5 minimum wage (80%). Survival analysis was performed using the Kaplan-Meier method and the Cox proportional hazards model adjusting the results for age, gender, educational status, predialysis care, first therapy, PD modality, calendar year, and comorbidities. RESULTS: There were no differences in technique (log rank test χ² = 4.36) and patient (log rank test χ² = 2.92) survival between the groups. In the multivariate analysis, low family income remained not associated either to worse technique survival (hazard ratio [HR] = 1.29; 95% confidence interval [CI] = 0.91 to 1.84) or to patient survival (HR = 1.40; 95% CI = 0.99 to 1.99). CONCLUSIONS: According to these results, economic status is not independently associated with outcomes in this large cohort and should not be considered a barrier for PD indication.