Comprehensive Geriatric Assessment in Kidney Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorInstitute for Clinical and Experimental Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
kidney transplant candidates aged 60+ years
kidney transplant recipients aged 60+ years
Disqualifiers
kidney transplant candidates aged below 60 years
kidney transplant recipients aged below 60 years
Trial population
Kidney transplant candidates and kidney transplant recipients aged 60+ years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Functional geriatric assessment
Procedure/SurgeryExamination of physical and mental status using standardized tests.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Non-frail1 intervention
Group B: Pre-frail1 intervention
Group C: Frail1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2020-20402
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.
Time frame
2020-20403
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).
Time frame
2020-20404
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).
Time frame
2020-2040Sponsors and contacts
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Source ClinicalTrials.gov