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临床试验/NCT06104696
NCT06104696招募中不适用

Comprehensive Geriatric Assessment in Kidney Transplantation

Institute for Clinical and Experimental Medicine1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events)

研究概览

简要总结

This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.

详细描述

Kidney transplantation represents the best therapeutical option in patients in end stage kidney disease. At present, increasing number of older patients are referred for kidney transplantation. Patients' functional status has been shown to be associated with transplant outcomes.

The comprehensive geriatric assessment (CGA) of functional and mental status in older kidney transplant candidates might play an important and supportive role in the pre-transplant evaluation process, including acceptance for transplantation. In kidney transplant recipients, this examination might be useful to evaluate the impact of pre-transplant status on post-transplant course. Also in KTR, CGA may contribute to the improvement of functional status and quality of life independently from the graft function.

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

入选标准

  • kidney transplant candidates aged 60+ years
  • kidney transplant recipients aged 60+ years

排除标准

  • kidney transplant candidates aged below 60 years
  • kidney transplant recipients aged below 60 years

结局指标

主要结局

Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events)

时间窗: 2020-2040

Outcomes of kidney transplantation based on both geriatric and nephrologic evaluation. Short- and long-term patient and graft survival, graft function, post-transplant related adverse events (infection rate, MACE, death, days of hospitalisation).

Frailty syndrome (Fried frailty phenotype)

时间窗: 2020-2040

Geriatric assessment of frailty syndrome in kidney transplant candidates and recipients. Evaluation of frailty syndrome based on Fried frailty phenotype, Short Physical Performance Battery (SPPB) and complex comprehensive geriatric assessment including cognitive frailty (Montreal Cognitive Assessment MoCA).

Depressive syndrome (amount of depressive symptoms measured by GDS scale)

时间窗: 2020-2040

Depressive syndrome in geriatric kidney transplant candidates and recipients. amount of depressive symptoms measured by GDS (Geriatric Depression Scale) scale by Yesavage.

Acceptance for kidney transplantation (Number of patients listed for kidney transplantation and number of transplanted patients)

时间窗: 2020-2040

Acceptance for kidney transplantation based on both geriatric and nephrologic evaluation. Number of patients listed for kidney transplantation,number of transplanted patients and number of patients not accepted for transplantation.

Functional status evaluated by comprehensive geriatric assessment

时间窗: 2020-2040

Functional status evaluated by comprehensive geriatric assessment in geriatric kidney transplant candidates and recipients including evaluation of mobility (Short Physical Performance Battery, SPPB, walking speed m/s, muscle strenght measured by hand-grip) and cognition (Montreal Cognitive Assessment, MoCA), self-sufficiency and/or dysability (Activities of Daily Living, ADL, Instrumental Activities of Daily Living, IADL).

次要结局

未报告次要终点

研究者

发起方
Institute for Clinical and Experimental Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Silvie Rajnochova Bloudickova

Head of Outpatient Clinic of Deparment of Nephrology, Transplant Center

Institute for Clinical and Experimental Medicine

研究点 (1)

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