Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis
Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis
This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis
 and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a
 single center.
Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned
 modalities in chronic kidney disease (CKD) patients is the reality in the practice for both
 hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the
 initiation of the modality in less than 48 hours after implantation of the peritoneal
 catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the
 initiation of the method without a functional arteriovenous fistula, i.e., with a central
 venous catheter (nontunneled or tunneled).

 Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to
 unplanned HD, with the similar rates of infection and survival.

 On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when
 compared to HD, however the literature lacks in this kind of analysis in unplanned methods.

 Briefly, the workgroup will follow patients that would anyway start a Renal Replacement
 Therapy by an unplanned method and register Government payment for the therapy, including the
 therapy direct costs and the costs with events (internation, infection), access for dialysis,
 laboratory and CKD specific medications to performed a cost-effectiveness analysis in both
 groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).

 The workgroup is responsible for the placement of the catheters (PD and HD) using the
 Seldinger Technique.

 The study is unicentric, the therapy is continuous and necessary for the maintenance of life;
 therefore, no great difficult in the follow up is expected. A database with up-to-date
 information of patients will be functional during the study.

 A Markov model will be developed to assess the relative cost-effectiveness of different
 dialysis modality distribution scenarios versus current practice. The model considers a
 hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring
 dialysis and adopts payer perspective. Markov models have been used to model dialysis
 treatment in previous economic analyses and are widely accepted to be suitable for modelling
 chronic condition

 Statistical analysis plan:

 From the study protocol, the data will be entered in a spreadsheet and verified typographical
 errors and their analysis will be performed using the statistical program Statistical
 Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA,
 2012).

 Considering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8
 and cost difference detection between groups of 15%, the calculated sample size for each
 group is 94 patients.

 Initially descriptive analysis will be done for all patients treated in the period,
 calculated measures of central tendency and dispersion for continuous variables and
 frequencies for categorical variables.

 For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized
 Linear Model (GENMOD) procedure will be used.

 Chi Square will be used to compare categorical variable between the two groups. T test or
 Mann-Whitney will be used to compare parametric continue variables.

 By the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be
 presented at the end of the study. A p-value of 5% or lower will be considered to be
 statistically significant
Inclusion Criteria:

 -  Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4
 with abrupt worsening requiring dialysis treatment immediately followed or not by
 nephrologists prior to Renal Replacement Therapy indication.

 Exclusion Criteria:

 -  Transitions between HD and PD

 -  Patients with functional arteriovenous fistula entering hemodialysis

 -  Patients with functional PD access implanted ate least 48h before the first use

 -  Patient or family trained in PD and/or with the right adequacy of the home