|- candidate number||14882|
|- NTR Number||NTR3989|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mei-2013|
|- Secondary IDs||12CEPPDEU1002 Baxter Healthcare|
|- Public Title||The influence of chronic exposure to low glucose and its degradationproducts dialysate on the peritoneal membrane.|
|- Scientific Title||The influence of chronic exposure to low glucose and its degradation products dialysate on the peritoneal membrane.|
|- hypothesis||A reduced peritoneal exposure to glucose and thereby to glucose degradation products will influence the incidence and severity of peritonitis and may modify peritoneal membrane characteristics.|
|- Healt Condition(s) or Problem(s) studied||Peritoneal dialysis, Glucose metabolism, Peritonitis|
|- Inclusion criteria||Retrospective analysis in a database consisting of data collected in the past, that were obtained in normal clinisal patient care. |
|- Exclusion criteria||Incomplete data|
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jun-2013|
|- planned closingdate||1-jun-2015|
|- Target number of participants||100|
|- Interventions||no intervention|
|- Primary outcome||incidence and severity of peritonitis|
|- Secondary outcome||effects on the peritoneal membrane|
|- Timepoints||2013: submission of abstracts on the first results to ADC congress.
2014: submission of a paper.
2015: submission of the final report, including biomarkers|
|- Trial web site|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||Prof.dr R.T. Krediet|
|- CONTACT for SCIENTIFIC QUERIES||Prof.dr R.T. Krediet|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||The PI has 500 publications in scientific journals and an H index of 52|
|- Brief summary||Death and renal transplantation are the main reasons for discontinuation of peritoneal dialysis, but peritonitis and membrane problems, such as ultrafiltration failure and encapsulating peritoneal sclerosis are also important reasons for discontinuation. Membrane failure can be caused by peritonitis and by the continuous exposure to dialysis solutions. Only few quantitative data is available on possible relationships between the severity of peritonitis and/or causative micro-organisms and the induction of membrane failure, although encapsulating peritoneal sclerosis is often preceded by a period of slowly resolving or recurrent peritonitis . The clinical observation that membrane failure can occur in some long-term patients who never had peritonitis, points to the importance of exposure to dialysis solutions. These are regarded bioincompatible, because of the extremely high glucose concentrations, presence of glucose degradation products (GDP), lactate and acidity.
Very little studies on glucose toxicity have been done in PD patients. We found that the effluent concentration of the advanced glycosylation end product pentosidine inc eased with the duration of PD Davies et al. reported that CAPD patients with an increase in the dialysate/plasma concentration of creatinine during follow-up of 5 years had a larger peritoneal exposure to glucose (and GDPs), than the ones without this complication.
The aim of the study is to investigate whether a reduced peritoneal exposure to glucose and thereby to glucose degradation products influences the incidence and severity of peritonitis, estimated by effluent leucocyte counts, and whether these effects are associated with peritoneal membrane characteristics after recovery from the acute infection in patients treated with chronic peritoneal dialysis.
An analysis will be done in two AMC cohorts. The first cohort comprises every peritonitis episode in each patient since 1979 till today. The data-base contains the causative micro-organism from every episode, the severity of inflammatory reaction, antibiotic treatment and the time-course. The 2nd cohort is on the yearly performed standard peritoneal permeability analysis (SPA), performed since 1990 in all patients willing to participate. The data-base contains the results on peritoneal transport of low molecular weight solutes, fluid kinetics and transport of macromolecules. Two cohorts will be compared: one from the period 1990-1997 (period 1) and the other one from the period 2005-2011 (period 2) with regard to the incidence and severity of peritonitis and its effects on the peritoneal membrane characteristics, including effluent biomarkers. In period 1 all patients were only treated with conventional dialysis solutions, high in glucose degradation products . In period 2 all patients received a more biocompatible solution.
|- Main changes (audit trail)|
|- RECORD||13-mei-2013 - 22-mei-2013|