Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent. An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime. 3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.
Please see study protocol and http://www.pedpd.org
Study Type
OBSERVATIONAL
Enrollment
500
Two parietal peritoneal samples, each 1 cm² x 0.3 cm in depth and three omental tissue samples, each 1 cm² in size will be obtained. Biopsy sampling will be performed in all groups. This is an observational not an interventional trial.
University of Alabama at Birmingham
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
RECRUITINGThe Children´s Hospital of Philadelphia
Narberth, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGDepartment of Pediatrics, Medical University Vienna
Vienna, Austria
Peritoneal vasculopathy (lumen vessel ratio)
Digital quantification of degree of vasculopathy, i.e the lumen vessel ratio. Healthy children have a L/V ratio of about 0.7. lower values represent vasculopathy with lumen narrowing, 0 is complete obliteration of the vessel. This measurements will be accompanied by molecular analysis of pathomechanisms (including omics Technology)
Time frame: Two years (Mean PD treatment time)
Number of vessels per peritoneal membrane area (per mm²)
Digital histomorphometry of small vessel density per mm² submesothelial section area analysed.
Time frame: at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation
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UZ Ghent
Ghent, Belgium
RECRUITINGUniversity Children's Hospital
Prague, Czechia
RECRUITINGService de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
Lyon, France
RECRUITINGUniversity Children's Hospital
Strasbourg, France
RECRUITINGDepartment of Medicine I (Nephrology), University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversity Children's Hospital
Berlin, Germany
ACTIVE_NOT_RECRUITING...and 16 more locations