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Clinical Trials/NCT05705011
NCT05705011
Completed
N/A

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.

Grigore T. Popa University of Medicine and Pharmacy1 site in 1 country240 target enrollmentMarch 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
CKD Stage 4
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Enrollment
240
Locations
1
Primary Endpoint
Time to initiate dialysis.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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?
Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 12, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Hani Hussien

Doctor

Grigore T. Popa University of Medicine and Pharmacy

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Time to initiate dialysis.

Time Frame: 36 months

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

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).

Study Sites (1)

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