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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05705011
Other study ID # Nephrogeriatrics
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date March 12, 2023

Study information

Verified date February 2024
Source Grigore T. Popa University of Medicine and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ]. The main question[s] it aims to answer are: - What determines the time to initiate dialysis? Cognitive impairment or frailty? - What does predict the time to death? Presence of frailty or cognitive impairment? - What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date March 12, 2023
Est. primary completion date March 5, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients age 65 years or older. - CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 separated by more than 3 months. Exclusion Criteria: - Patients younger than 65 years old. - Chronic kidney disease stages 1,2, and 3. - Dialysis dependence - History of kidney transplantation. - Initial visit with the health care provider. - Recent acute kidney injury. - Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty) - Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment - Patients who are blind or with limb amputation. - Patients who refuse to participate.

Study Design


Locations

Country Name City State
Romania University of Medicine and Pharmacy "Grigore T. Popa" Iasi

Sponsors (1)

Lead Sponsor Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to death The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5). 36 months
Primary Time to initiate dialysis. The time from the assessment moment to start dialysis of an older adult with advanced CKD ( 36 months
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