International Pediatric Peritoneal Biobank
International (Pediatric) Peritoneal Biobank
This study is collecting tissue samples from children on peritoneal dialysis to see how the treatment affects their bodies and health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 1 Day to 90 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 26 sites (Birmingham, Alabama and 25 other locations) |
| Trial ID | NCT01893710 on ClinicalTrials.gov |
What this trial studies
This study aims to collect peritoneal membrane biopsies from children undergoing peritoneal dialysis to investigate morphological changes and complications associated with the treatment. Biopsies will be taken during catheter insertion, abdominal surgeries, or renal transplantation. The research will analyze tissue characteristics and correlate them with treatment modalities and patient outcomes, providing insights into the unique pediatric population. This observational study seeks to fill the knowledge gap regarding peritoneal dialysis effects in children.
Who should consider this trial
Good fit: Ideal candidates include children aged 0 to 90 years with chronic kidney disease requiring peritoneal dialysis or those undergoing elective abdominal surgery.
Not a fit: Patients with significant abdominal complications, disseminated tumor disease, or critical heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of peritoneal dialysis complications in children, leading to improved treatment strategies.
How similar studies have performed: While studies on adult peritoneal dialysis have shown significant findings, this specific approach in children is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 25 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Active_not_recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- The Children´s Hospital of Philadelphia — Narberth, Pennsylvania, United States (Active_not_recruiting)
- Department of Pediatrics, Medical University Vienna — Vienna, Austria (Recruiting)
- UZ Ghent — Ghent, Belgium (Recruiting)
- University Children's Hospital — Prague, Czechia (Recruiting)
- Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant — Lyon, France (Recruiting)
- University Children's Hospital — Strasbourg, France (Recruiting)
- Department of Medicine I (Nephrology), University of Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- University Children's Hospital — Berlin, Germany (Active_not_recruiting)
- University Children's Hospital — Cologne, Germany (Recruiting)
- University Children's Hospital — Essen, Germany (Recruiting)
- UKE, University Children´s Hospital — Hamburg, Germany (Recruiting)
- KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg — Marburg, Germany (Recruiting)
- University Children's Hospital — Budapest, Hungary (Recruiting)
- University Children'Hospital — Genova, Italy (Active_not_recruiting)
- University Children's Hospital — Milan, Italy (Recruiting)
- Pediatric Nephrology, Dialysis and Transplant Unit — Padova, Italy (Active_not_recruiting)
- University children's Hospital — Vilnius, Lithuania (Recruiting)
- Paediatric CAPD unit, Kuala Lumpur Hospital — Kuala Lumpur, Malaysia (Active_not_recruiting)
- Krakow, Jagiellonian University Medical College — Krakow, Poland (Recruiting)
- Hospital Universitario Materno-Infantil Vall d' Hebron — Barcelona, Spain (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Active_not_recruiting)
- Children's Hospital, Inselspital, Bern University Hospital and University of Bern — Bern, Switzerland (Active_not_recruiting)
- University Children's Hospital — Adana, Turkey (Türkiye) (Recruiting)
- Cerrahpasa School of Medicine — Istanbul, Turkey (Türkiye) (Active_not_recruiting)
Study contacts
- Principal investigator: Claus P Schmitt, MD — University of Heidelberg, Center for Pediatric and Adolescent Medicine
- Study coordinator: Claus P Schmitt, Prof
- Email: claus.peter.schmitt@med.uni-heidelberg.de
- Phone: +49 6221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.