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临床试验/NCT06495385
NCT06495385进行中(未招募)不适用

Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2024年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
535
试验地点
1
主要终点
Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups

研究概览

简要总结

The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. This is also reflected in the very low number of pre-emptive renal transplantations.

In order to reduce the number of dialysis patients, the French state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with Chronic Kidney Disease stage 4 and 5.

详细描述

The aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All stage 4 and 5 Chronic Kidney Disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of AURA SANTE

排除标准

  • Patients without a medical follow up during this year (2021)
  • Patients with insufficient or no data during the 24 month of follow up period
  • Active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process.

结局指标

主要结局

Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups

时间窗: Month : 6, 12, 18 and 24

The estimated Glomerular filtration rate is estimated with the CKD-EPI formula adjusted for 1.73m2 of body surface area and produced in ml/min/1.73m2 of body surface area. The CKD-EPI formula used is as follows: The conversion of serum creatinine level for the CKD-EPI formula was done as follows: creatinine level (mg/dl) = creatinine level (μmol/l) × 0.01131222 (considering that 1 mg/dl creatinine = 88.4 μmol/l creatinine). A GFR of 60 or more is within the normal range. A GFR below 60 may indicate kidney disease.

次要结局

  • Evolution of dietary parameters : protein consumption(Month : 6, 12, 18 and 24)
  • Evolution of patients' survival for every group during the study period(Month : 6, 12, 18 and 24)
  • Evolution of preemptive transplantation during the study period for the three study groups(Month : 6, 12, 18 and 24)
  • Evolution of biological parameters : alkaline reserve levels(Month : 6, 12, 18 and 24)
  • Evolution of renal survival over the follow up period for every group(Month : 6, 12, 18 and 24)
  • Evolution of biological parameters : plasma calcium(Month : 6, 12, 18 and 24)
  • Evolution of biological parameters : phosphate(Month : 6, 12, 18 and 24)
  • Evolution of biological parameters : Haemoglobin(Month : 6, 12, 18 and 24)
  • Evolution of dietary parameters : salt consumption(Month : 6, 12, 18 and 24)
  • Evolution of biological parameters : parathyroid hormone(Month : 6, 12, 18 and 24)
  • Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)(Month : 6, 12, 18 and 24)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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