International (Pediatric) Peritoneal Biobank
- Conditions
- Kidney Failure, ChronicTransplantationHealthyPeritoneal Dialysis Complication
- Interventions
- Procedure: biopsy sampling
- Registration Number
- NCT01893710
- Lead Sponsor
- Heidelberg University
- Brief 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.
- Detailed Description
Please see study protocol and
http://www.pedpd.org
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post PD and with functioning graft biopsy sampling 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. chronic kidney disease biopsy sampling Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion) Peritoneal dialysis biopsy sampling Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
- Primary Outcome Measures
Name Time Method Peritoneal vasculopathy (lumen vessel ratio) Two years (Mean PD treatment time) Digital quantification of degree of vasculopathy, i.e the lumen vessel ratio. Healthy children have a L/V ratio of about 0.7. lower values represent vasculopathy with lumen narrowing, 0 is complete obliteration of the vessel.
This measurements will be accompanied by molecular analysis of pathomechanisms (including omics Technology)
- Secondary Outcome Measures
Name Time Method Number of vessels per peritoneal membrane area (per mm²) at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation Digital histomorphometry of small vessel density per mm² submesothelial section area analysed.
Trial Locations
- Locations (19)
Department of Pediatrics, Medical University Vienna
🇦🇹Vienna, Austria
Krakow, Jagiellonian University Medical College
🇵🇱Krakow, Poland
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Cerrahpasa School of Medicine
🇹🇷Istanbul, Turkey
Department of Medicine I (Nephrology), University of Heidelberg
🇩🇪Heidelberg, BW, Germany
University children's Hospital
🇱🇹Vilnius, Lithuania
The Children´s Hospital of Philadelphia
🇺🇸Narberth, Pennsylvania, United States
UZ Ghent
🇧🇪Ghent, Belgium
University Children's Hospital
🇹🇷Adana, Turkey
UKE, University Children´s Hospital
🇩🇪Hamburg, Germany
KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg
🇩🇪Marburg, Germany
University Children'Hospital
🇮🇹Genova, Italy
Pediatric Nephrology, Dialysis and Transplant Unit
🇮🇹Padova, Italy
Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
🇫🇷Lyon, France
Paediatric CAPD unit, Kuala Lumpur Hospital
🇲🇾Kuala Lumpur, Malaysia
Children's Hospital, Inselspital, Bern University Hospital and University of Bern
🇨🇭Bern, Switzerland
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Hospital Universitario Materno-Infantil Vall d' Hebron
🇪🇸Barcelona, Spain