International (Pediatric) Peritoneal Biobank

Обзор

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.

Подробное описание

Please see study protocol and

http://www.pedpd.org

Вмешательства

• Процедура 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.

Первичные конечные точки

• Peritoneal vasculopathy (lumen vessel ratio) [Срок оценки: Two years (Mean PD treatment time)]

Вторичные конечные точки (1)

• Number of vessels per peritoneal membrane area (per mm²) [Срок оценки: at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Германия · 6 центров

• 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

США · 3 центра

• University of Alabama at Birmingham — Birmingham
• Children's Mercy Hospital — Kansas City
• The Children´s Hospital of Philadelphia — Narberth

Италия · 3 центра

• University Children'Hospital — Genova
• University Children's Hospital — Milan
• Pediatric Nephrology, Dialysis and Transplant Unit — Padova

Франция · 2 центра

• Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant — Lyon
• University Children's Hospital — Strasbourg

Turkey (Türkiye) · 2 центра

• University Children's Hospital — Adana
• Cerrahpasa School of Medicine — Istanbul

Австрия · 1 центр

• Department of Pediatrics, Medical University Vienna — Vienna

Бельгия · 1 центр

• UZ Ghent — Ghent

Чехия · 1 центр

• University Children's Hospital — Prague

Венгрия · 1 центр

• University Children's Hospital — Budapest

Литва · 1 центр

• University children's Hospital — Vilnius

Малайзия · 1 центр

• Paediatric CAPD unit, Kuala Lumpur Hospital — Kuala Lumpur

Польша · 1 центр

• Krakow, Jagiellonian University Medical College — Krakow

Испания · 1 центр

• Hospital Universitario Materno-Infantil Vall d' Hebron — Barcelona

Швеция · 1 центр

• Karolinska University Hospital — Stockholm

Швейцария · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT01893710 · IPPB Biobank · University of Heidelberg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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