The purpose of this study is to evaluate whether addition of bemiparin, once daily in icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients presenting functional disorders related to ultrafiltration deficit and/or high transport.
Peritoneal dysfunction is a common complication in patients in stable treatment with peritoneal dialysis. This peritoneal dysfunction is defined by an elevated creatinine transport and lowered standardized ultrafiltration capacity. The aim of this study is to evaluate the efficacy of the addition of bemiparin to icodextrin solution in patients in peritoneal dialysis with peritoneal transport disorders. The eligible patients are randomly assigned to receive the icodextrin solution with bemiparin or icodextrin solution without bemiparin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Hospital Regional Universitario Carlos Haya
Málaga, Andalusia, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Efficacy: Peritoneal function defined according to the standardized ultrafiltration capacity and/or estimated peritoneal creatinine transport estimated by D/P and mass transfer coefficient during randomized treatment
Safety: Incidence of peritonitis during the randomized treatment period, defined by a cell count of peritoneal effluent with more than 100 leukocytes per mm3 with 50% or more polymorphonuclear cells
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