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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-frail | Group of patients which will meet the criteria for non-frail according to the result of functional examination. |
| |
| Pre-frail | Group of patients which will meet the criteria for pre-frail according to the result of functional examination. |
| |
| Frail | Group of patients which will meet the criteria for frail according to the result of functional examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional geriatric assessment | Procedure | Examination of physical and mental status using standardized tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frailty syndrome (Fried frailty phenotype) | 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). | 2020-2040 |
| Acceptance for kidney transplantation (Number of patients listed for kidney transplantation and number of transplanted patients) | 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. | 2020-2040 |
| Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events) | 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). | 2020-2040 |
| Functional status evaluated by comprehensive geriatric assessment | 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). | 2020-2040 |
| Depressive syndrome (amount of depressive symptoms measured by GDS scale) | Depressive syndrome in geriatric kidney transplant candidates and recipients. amount of depressive symptoms measured by GDS (Geriatric Depression Scale) scale by Yesavage. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant candidates and kidney transplant recipients aged 60+ years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvie Rajnochova Bloudickova, MD,PhD | Contact | 261362223 | +420 | sibl@ikem.cz |
| Hana Vankova, MD,PhD | Contact | 261362223 | +420 | ha.van@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Silvie Rajnochova Bloudickova, MD,PhD | Department of Nephrology, Institute for Clinical and Experimental Medicine | Study Director |
| Hana Vankova, MD,PhD | Charles University, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology Transplant Centre IKEM | Recruiting | Prague | 140 21 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30506632 | Result | Kobashigawa J, Dadhania D, Bhorade S, Adey D, Berger J, Bhat G, Budev M, Duarte-Rojo A, Dunn M, Hall S, Harhay MN, Johansen KL, Joseph S, Kennedy CC, Kransdorf E, Lentine KL, Lynch RJ, McAdams-DeMarco M, Nagai S, Olymbios M, Patel J, Pinney S, Schaenman J, Segev DL, Shah P, Singer LG, Singer JP, Sonnenday C, Tandon P, Tapper E, Tullius SG, Wilson M, Zamora M, Lai JC. Report from the American Society of Transplantation on frailty in solid organ transplantation. Am J Transplant. 2019 Apr;19(4):984-994. doi: 10.1111/ajt.15198. Epub 2018 Dec 22. | |
| 26997416 |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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blood and urine samples
| 2020-2040 |
| Result |
| Cesari M, Marzetti E, Thiem U, Perez-Zepeda MU, Abellan Van Kan G, Landi F, Petrovic M, Cherubini A, Bernabei R. The geriatric management of frailty as paradigm of "The end of the disease era". Eur J Intern Med. 2016 Jun;31:11-4. doi: 10.1016/j.ejim.2016.03.005. Epub 2016 Mar 18. |
| 8105269 | Result | Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v. |
| 30890577 | Result | Haugen CE, Chu NM, Ying H, Warsame F, Holscher CM, Desai NM, Jones MR, Norman SP, Brennan DC, Garonzik-Wang J, Walston JD, Bingaman AW, Segev DL, McAdams-DeMarco M. Frailty and Access to Kidney Transplantation. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):576-582. doi: 10.2215/CJN.12921118. Epub 2019 Mar 19. |
| 25336440 | Result | Turner G, Clegg A; British Geriatrics Society; Age UK; Royal College of General Practioners. Best practice guidelines for the management of frailty: a British Geriatrics Society, Age UK and Royal College of General Practitioners report. Age Ageing. 2014 Nov;43(6):744-7. doi: 10.1093/ageing/afu138. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |