International (Pediatric) Peritoneal Biobank

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 90
Healthy Volunteers: t
View:

• Age 0 to 90 years

• CKD 5D, peritoneal dialysis and

• Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)

• Patients post PD and post Tx

• Oral and written consent

• Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively

Locations
United States
Alabama
University of Alabama at Birmingham
ACTIVE_NOT_RECRUITING
Birmingham
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Pennsylvania
The Children´s Hospital of Philadelphia
ACTIVE_NOT_RECRUITING
Narberth
Other Locations
Austria
Department of Pediatrics, Medical University Vienna
RECRUITING
Vienna
Belgium
UZ Ghent
RECRUITING
Ghent
France
Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
RECRUITING
Lyon
University Children's Hospital
RECRUITING
Strasbourg
Germany
University Children's Hospital
ACTIVE_NOT_RECRUITING
Berlin
University Children's Hospital
RECRUITING
Cologne
University Children's Hospital
RECRUITING
Essen
UKE, University Children´s Hospital
RECRUITING
Hamburg
Department of Medicine I (Nephrology), University of Heidelberg
RECRUITING
Heidelberg
KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg
RECRUITING
Marburg
Hungary
University Children's Hospital
RECRUITING
Budapest
Italy
University Children'Hospital
ACTIVE_NOT_RECRUITING
Genova
University Children's Hospital
RECRUITING
Milan
Pediatric Nephrology, Dialysis and Transplant Unit
ACTIVE_NOT_RECRUITING
Padua
Lithuania
University children's Hospital
RECRUITING
Vilnius
Malaysia
Paediatric CAPD unit, Kuala Lumpur Hospital
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Poland
Krakow, Jagiellonian University Medical College
RECRUITING
Krakow
Spain
Hospital Universitario Materno-Infantil Vall d' Hebron
RECRUITING
Barcelona
Sweden
Karolinska University Hospital
ACTIVE_NOT_RECRUITING
Stockholm
Switzerland
Children's Hospital, Inselspital, Bern University Hospital and University of Bern
ACTIVE_NOT_RECRUITING
Bern
Turkey
University Children's Hospital
RECRUITING
Adana
Cerrahpasa School of Medicine
ACTIVE_NOT_RECRUITING
Istanbul
Contact Information
Primary
Claus P Schmitt, Prof
claus.peter.schmitt@med.uni-heidelberg.de
+49 6221 56
Time Frame
Start Date: 2011-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 500
Treatments
Control
'Biopsy sampling': Peritoneal biopsies without kidney disease, i.e. diseases not related to the kidney and not affecting the peritoneum. This group is accomplished.
chronic kidney disease
Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)
Peritoneal dialysis
Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
Post PD and with functioning graft
Samples will also be collected and analysed from patients with renal transplantation after PD at time of and tenckhoff catheter removal several weeks after Tx or other intercurrent abdominal surgery.
Sponsors
Leads: Heidelberg University

This content was sourced from clinicaltrials.gov