Informations générales (source: ClinicalTrials.gov)
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
juillet 2008
janvier 2015
29 juin 2024
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 consent. Patients will be randomized 1/1 in two arms : 250
patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up;
250 patients in the "geriatric follow-up" arm will have both their usual nephrology
follow-up and a geriatric follow-up.The aim of the study is to determine if a
systematized gerontologist evaluation delay the occurrence of a composite primary
endpoint : death, dementia, depression and severe dependency. The hypothesis is that the
functional and vital prognosis of a patient with renal insufficiency depends not only on
common and classical factors but also on cognitive and psychological functions and
dependence, particularly in elderly patients.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Nantes - Nantes - France | Vincent ESNAULT, Profesor | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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