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OpenTrials
Completed

NCT Number: NCT05705011

Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.

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?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Time to death

    Time frame: 36 months

    The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5).

  2. Time to initiate dialysis.

    Time frame: 36 months

    The time from the assessment moment to start dialysis of an older adult with advanced CKD (

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Registry information

Official study title

Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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