Status:
UNKNOWN
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Lead Sponsor:
Nantes University Hospital
Conditions:
Renal Insufficiency
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed...
Eligibility Criteria
Inclusion
- Patients aged of 75 years old or more,
- Chronic kidney disease stage 5 defined by :
- either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient whatever the duration of previous monitoring by the nephrologist("Pre-dialysis cohort"),
- or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("post-dialysis cohort"),
- Signed and dated informed consent.
Exclusion
- Moderately severe to severe dementia (MMS ≤ 15),
- Major depression and/or GDS-15 \> 10/15,
- Severe dependency (ADL \< 3/6),
- Psychosis, mutism or aphasia,
- Malignancy or any pathology with life expectancy \< one year,
- Ongoing specialized geriatric care
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00847275
Start Date
July 1 2008
End Date
January 1 2015
Last Update
January 26 2010
Active Locations (1)
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1
CHU de Nantes
Nantes, France