Status:

UNKNOWN

Quality of Life of Frail Aged Patients in Incremental Hemodialysis

Lead Sponsor:

Centre Hospitalier Universitaire de Besancon

Conditions:

Renal Dialysis

Kidney Failure, Chronic

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold...

Eligibility Criteria

Inclusion

  • For all patients (incident HD patients):
  • Patient aged over 60 years
  • Signature of informed consent
  • Affiliation to a French social security or receiving such a scheme
  • Patient with Chronic Kidney Disease Stage 5 (GFR \<15 ml/min/1.73m2)
  • Urine output \> 0,5 L per day
  • Kru ≥ 2 ml/min
  • Outpatient with scheduled start of HD
  • Understand and read french
  • For randomized patients (frail incident HD patients):
  • \- Frailty according to L. Fried criteria: score greater than or equal to 3/5

Exclusion

  • Inability to understand the reasons for the study; psychiatric disorders
  • Active and/or treated neoplastic disease
  • Scheduled kidney transplantation within 6 months
  • Solid organ transplanted patient receiving immunosuppressive therapy
  • Estimated life expectancy \< 6 months
  • Patient with diagnosis of severe chronic heart failure (\> 2 congestive heart failure episodes requiring hospitalization in the year preceding the start of HD)
  • Legal disability or limited legal capacity
  • Patient without health insurance
  • Pregnant
  • Patient in the period of exclusion of another study
  • Uncooperative patient

Key Trial Info

Start Date :

May 9 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2022

Estimated Enrollment :

783 Patients enrolled

Trial Details

Trial ID

NCT03782519

Start Date

May 9 2019

End Date

December 1 2022

Last Update

April 5 2022

Active Locations (1)

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Centre Hospitalier Universitaire de Besançon

Besançon, France, 25000

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