International Pediatric Peritoneal Biopsy Study
Status: | Recruiting |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 5/10/2018 |
Start Date: | February 2011 |
End Date: | March 2020 |
Contact: | Claus P Schmitt, MD |
Email: | claus.peter.schmitt@med.uni-heidelberg.de |
Phone: | +49 6221 56 |
International Pediatric Peritoneal Biopsy Study in Children on PD and Healthy Controls
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.
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.
Please see study protocol and
http://www.pedpd.org
http://4c-study.org
http://www.pedpd.org
http://4c-study.org
Inclusion Criteria:
- Age 0 to 21 years. 0-70 years in patients with normal renal function
- CKD 5d, peritoneal dialysis and
- Patients with normal renal function and elective abdominal surgery due to limited
pathology not affecting the Peritoneum, 0-70 years
- Oral and written consent
Exclusion Criteria:
- Contraindications to peritoneal dialysis, such as severe abdominal adhesions,
malformations and inflammations
- Pregnancy
- Preterm babies (below 37 weeks of gestational age)
- If serum hemoglobin < 8 g/dl in children and < 10 g/dl in newborns
We found this trial at
4
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2401 Gillham Rd
Kansas City, Missouri 64108
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Bradley A. Warady, MD
Phone: 816-234-3010
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Vienna,
Principal Investigator: Klaus Arbeiter, MD
Phone: +43 1404003257
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