跳至主要内容
临床试验/NCT02207751
NCT02207751撤回不适用

Improving Outcomes in Peritoneal Dialysis: Identification and Characterization of Optimal Clinical Practice to Enhance Peritoneal Dialysis Catheter Functionality, Minimize Access-related Complications and Promote Peritoneal Dialysis as an Initiating Therapeutic Modality for Chronic Kidney Disease.

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)

研究概览

简要总结

The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and the best way to collect data regarding their function in England, Wales and Northern Ireland.

Phase 1: We will carry out a detailed examination of existing returned pilot data with emphasis on data fields with poor data completeness and perform root cause analysis, and assess deficiencies in data field definition to identify improvements to be implemented. We will construct and disseminate electronic survey material to all study centres with targeted visits by the Principle Investigator undertaken. These visits will facilitate insight into local organization of data collection including interaction with designated individuals responsible for data returns. PD training days will be organized with emphasis on clinical practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics will be linked to existing acquired PD patient information to ensure the accuracy of collected data. An online data acquisition system will be developed to allow direct data entry from centres.

Phase 2: On-going and sustained data acquisition performed on a prospective basis.

Phase 3: Primary data analysis including clinical practice variation in England, Wales and Northern Ireland to identify site specific PD catheter functionality variation. Additionally, patient and site specific characteristics that predict clinical outcomes in PD will be identified and characterised.

Phase 4: Clinical guidelines will be developed.

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult (16 years or over) patient requiring first PD catheter placement

排除标准

  • Patient less than 16 years

结局指标

主要结局

Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)

时间窗: 1 Year

1. Functional (mechanical) catheter failure 2. Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage \& Bowel Perforation

次要结局

  • Infection events not resulting in catheter failure(Within 1 Year)
  • Leak events not resulting in catheter failure(Within 1 Year)
  • Missing Data(Baseline & 1 Year)
  • Co-morbid Hospitalization Events(Within 1 Year)
  • Time to catheter failure(Within 1 Year)
  • Mortality (all cause)(Within 1 Year)
  • Modality change(Within 1 Year)
  • Catheter non-usage(Within 1 Year)

研究者

申办方类型
Other
责任方
Sponsor

相似试验