International (Pediatric) Peritoneal Biobank
Recruiting · NCT01893710 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heidelberg University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
26 locations listed across 3 US states.
- 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
- University Children's Hospital - Adana, Turkey (Türkiye)
- Hospital Universitario Materno-Infantil Vall d' Hebron - Barcelona, Spain
- University Children's Hospital - Berlin, Germany
- Children's Hospital, Inselspital, Bern University Hospital and University of Bern - Bern, Switzerland
- University Children's Hospital - Budapest, Hungary
- University Children's Hospital - Cologne, Germany
- University Children's Hospital - Essen, Germany
- University Children'Hospital - Genova, Italy
- UZ Ghent - Ghent, Belgium
- UKE, University Children´s Hospital - Hamburg, Germany
- Cerrahpasa School of Medicine - Istanbul, Turkey (Türkiye)
- Krakow, Jagiellonian University Medical College - Krakow, Poland
- Paediatric CAPD unit, Kuala Lumpur Hospital - Kuala Lumpur, Malaysia
- Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant - Lyon, France
- KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg - Marburg, Germany
- University Children's Hospital - Milan, Italy
- Pediatric Nephrology, Dialysis and Transplant Unit - Padova, Italy
- University Children's Hospital - Prague, Czechia
- Karolinska University Hospital - Stockholm, Sweden
- University Children's Hospital - Strasbourg, France
- Department of Pediatrics, Medical University Vienna - Vienna, Austria
- University children's Hospital - Vilnius, Lithuania
- Department of Medicine I (Nephrology), University of Heidelberg - Heidelberg, Baden-Wurttemberg, Germany