International (Pediatric) Peritoneal Biobank
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biopsy sampling.
- Who it may be relevant to
- Registry conditions: Kidney Failure, Chronic, Peritoneal Dialysis Complication, Transplantation, Healthy. Basic parameters: 1 Day — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Czechia, France +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Please see study protocol and
http://www.pedpd.org
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.
Primary outcome measures
- Peritoneal vasculopathy (lumen vessel ratio) [Time frame: Two years (Mean PD treatment time)]
Secondary outcome measures (1)
- Number of vessels per peritoneal membrane area (per mm²) [Time frame: at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Abdominal adhesions, malformation and inflammation beyond PD induced changes
- Patients with disseminated tumour disease
- Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk
- Pregnancy
- Preterm babies (below 37 weeks of gestational age)
- Serum hemoglobin < 10 g/dl in newborns and < 8 g/dl in children and adults
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Germany · 6 centers
- Department of Medicine I (Nephrology), University of Heidelberg — Heidelberg
- University Children's Hospital — Berlin
- University Children's Hospital — Cologne
- University Children's Hospital — Essen
- UKE, University Children´s Hospital — Hamburg
- KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg — Marburg
United States · 3 centers
- University of Alabama at Birmingham — Birmingham
- Children's Mercy Hospital — Kansas City
- The Children´s Hospital of Philadelphia — Narberth
Italy · 3 centers
- University Children'Hospital — Genova
- University Children's Hospital — Milan
- Pediatric Nephrology, Dialysis and Transplant Unit — Padova
France · 2 centers
- Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant — Lyon
- University Children's Hospital — Strasbourg
Turkey (Türkiye) · 2 centers
- University Children's Hospital — Adana
- Cerrahpasa School of Medicine — Istanbul
Austria · 1 center
- Department of Pediatrics, Medical University Vienna — Vienna
Belgium · 1 center
- UZ Ghent — Ghent
Czechia · 1 center
- University Children's Hospital — Prague
Hungary · 1 center
- University Children's Hospital — Budapest
Lithuania · 1 center
- University children's Hospital — Vilnius
Malaysia · 1 center
- Paediatric CAPD unit, Kuala Lumpur Hospital — Kuala Lumpur
Poland · 1 center
- Krakow, Jagiellonian University Medical College — Krakow
Spain · 1 center
- Hospital Universitario Materno-Infantil Vall d' Hebron — Barcelona
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Switzerland · 1 center
- Children's Hospital, Inselspital, Bern University Hospital and University of Bern — Bern
Publications
- Levai E, Marinovic I, Bartosova M, Zhang C, Schaefer B, Jenei H, Du Z, Drozdz D, Klaus G, Arbeiter K, Romero P, Schwenger V, Schwab C, Szabo AJ, Zarogiannis SG, Schmitt CP. Human peritoneal tight junction, transporter and channel expression in health and kidney failure, and associated solute transport. Sci Rep. 2023 Oct 13;13(1):17429. doi: 10.1038/s41598-023-44466-z. PMID 37833387
- Catar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jorres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu PMID 35185912
- Bartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. E PMID 34233458
Identifiers
NCT: NCT01893710 · IPPB Biobank · University of Heidelberg