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RECRUITING
NCT01893710

International (Pediatric) Peritoneal Biobank

Sponsor: Heidelberg University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Day - 90 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2011-02

Completion Date

2028-12

Last Updated

2024-12-04

Healthy Volunteers

Yes

Interventions

PROCEDURE

biopsy sampling

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.

Locations (26)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

The Children´s Hospital of Philadelphia

Narberth, Pennsylvania, United States

Department of Pediatrics, Medical University Vienna

Vienna, Austria

UZ Ghent

Ghent, Belgium

University Children's Hospital

Prague, Czechia

Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant

Lyon, France

University Children's Hospital

Strasbourg, France

Department of Medicine I (Nephrology), University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

University Children's Hospital

Berlin, Germany

University Children's Hospital

Cologne, Germany

University Children's Hospital

Essen, Germany

UKE, University Children´s Hospital

Hamburg, Germany

KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg

Marburg, Germany

University Children's Hospital

Budapest, Hungary

University Children'Hospital

Genova, Italy

University Children's Hospital

Milan, Italy

Pediatric Nephrology, Dialysis and Transplant Unit

Padova, Italy

University children's Hospital

Vilnius, Lithuania

Paediatric CAPD unit, Kuala Lumpur Hospital

Kuala Lumpur, Malaysia

Krakow, Jagiellonian University Medical College

Krakow, Poland

Hospital Universitario Materno-Infantil Vall d' Hebron

Barcelona, Spain

Karolinska University Hospital

Stockholm, Sweden

Children's Hospital, Inselspital, Bern University Hospital and University of Bern

Bern, Switzerland

University Children's Hospital

Adana, Turkey (Türkiye)

Cerrahpasa School of Medicine

Istanbul, Turkey (Türkiye)