Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2011-02-28
2028-12-31
Brief Summary
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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
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http://www.pedpd.org
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
chronic kidney disease
Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)
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.
Peritoneal dialysis
Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
90 Years
ALL
Yes
Sponsors
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Heidelberg University
OTHER
Responsible Party
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Claus Peter Schmitt
MD
Principal Investigators
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Claus P Schmitt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Heidelberg, Center for Pediatric and Adolescent Medicine
Locations
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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
Padua, , 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)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.2022.821681. eCollection 2022.
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. Epub 2021 Jul 8.
Related Links
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International Pediatric Peritoneal Dialysis Network
Other Identifiers
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University of Heidelberg
Identifier Type: OTHER
Identifier Source: secondary_id
IPPB Biobank
Identifier Type: -
Identifier Source: org_study_id