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临床试验/NCT01893710
NCT01893710招募中不适用

International (Pediatric) Peritoneal Biobank

Heidelberg University19 个研究点 分布在 13 个国家目标入组 500 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
19
主要终点
Peritoneal vasculopathy (lumen vessel ratio)

研究概览

简要总结

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.

详细描述

Please see study protocol and

http://www.pedpd.org

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Day 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Peritoneal vasculopathy (lumen vessel ratio)

时间窗: 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)

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claus Peter Schmitt

MD

Heidelberg University

研究点 (19)

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