Comprehensive Geriatric Assessment in Kidney Transplantation

Recruiting

• Conditions: Frailty Syndrome; Kidney Transplant; Complications; Depressive Syndrome
• Interventions: Procedure: Functional geriatric assessment

• Registration Number: NCT06104696
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-02
• Study First Submitted: 2023-08-04
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2025-01-02
• Study Completion: 2040-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-frail	Functional geriatric assessment	Group of patients which will meet the criteria for non-frail according to the result of functional examination.
Pre-frail	Functional geriatric assessment	Group of patients which will meet the criteria for pre-frail according to the result of functional examination.
Frail	Functional geriatric assessment	Group of patients which will meet the criteria for frail according to the result of functional examination.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nephrology Transplant Centre IKEM; 🇨🇿 Praha, Czechia