Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Not Applicable

• Conditions: Renal Insufficiency

• Registration Number: NCT00847275
• Lead Sponsor: Nantes University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First outcome reached among: - death, - occurrence of a severe dementia (MMS < 10),- major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria,- severe dependency (ADL < 3/6).	3 years

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level.	3 years

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France