Clinical trial NCT00847275: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Official title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency
Keywords: Elderly patients
renal insufficiency
gerontologic evaluation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 500
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 3 years
Secondary outcomes:
measure: Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: CHU NICE
name: Vincent ESNAULT, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Christian COMBE, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Muriel RAINFRAY, Profesor
role: STUDY_CHAIR
affiliation: CHU Brest
name: Tugdual TANQUEREL, Doctor
role: STUDY_CHAIR
affiliation: CHU de Brest
name: Armelle TILLY-GENTRIC, Profesor
role: STUDY_CHAIR
affiliation: CH Cholet
name: Mokhtar AMRANDI, Doctor
role: STUDY_CHAIR
affiliation: CH Cholet
name: Jacques d'AVIGNEAU, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Clermont-Ferrand
name: Patrice DETEIX, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Clermont-Ferrand
name: Bruno LESOURD, Profesor
role: STUDY_CHAIR
affiliation: CHU Colmar
name: Bernadette FALLER, Colmar
role: STUDY_CHAIR
affiliation: CHU Colmar
name: Nathalie SCHMITT, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Philippe ZAOUI, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Claire MILLET, Doctor
role: STUDY_CHAIR
affiliation: CHD La Roche sur Yon
name: Jean-Noël OTTAVIOLI, Doctor
role: STUDY_CHAIR
affiliation: CHD La Roche sur Yon
name: Pierre LERMITE, Doctor
role: STUDY_CHAIR
affiliation: CHRU LILLE
name: Eric BOULANGER, Doctor
role: STUDY_CHAIR
affiliation: CHRU LILLE
name: François PUISIEUX, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Limoges
name: Jean-Claude ALDIGIER, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Limoges
name: Jean-Pierre CHARMES, Doctor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Maurice LAVILLE, Profesor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Brigitte COMTE, Doctor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Michel LABEEUW, Profesor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Marc BONNEFOY, Profesor
role: STUDY_CHAIR
affiliation: CHU Marseille
name: Philippe BRUNET, Profesor
role: STUDY_CHAIR
affiliation: CHU Marseille
name: Sylvie BONIN-GUILLAUME, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Montpellier
name: Bernard CANAUD, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Montpellier
name: Claude JEANDEL, Profesor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Catherine DELCROIX, Doctor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Gilles BERRUT, Profesor
role: STUDY_CHAIR
affiliation: CHU NICE
name: Patrice BROCKER, Profesor
role: STUDY_CHAIR
affiliation: CHU Nîmes
name: Bernard BRANGER, Doctor
role: STUDY_CHAIR
affiliation: CHU Nîmes
name: Benoît de WAZIERES, Profesor
role: STUDY_CHAIR
affiliation: AP-HP (Hôpital Bichat)
name: François VRTOVSNIK, Profesor
role: STUDY_CHAIR
affiliation: AP-HP (Hôpital Bichat)
name: Fannie ONEN, Doctor
role: STUDY_CHAIR
affiliation: AP-HP (Hôpital Necker)
name: Dominique JOLY, Doctor
role: STUDY_CHAIR
affiliation: AP-HP (La Pitié-Salpétrière)
name: Gilbert DERAY, Profesor
role: STUDY_CHAIR
affiliation: AP-HP (La Pitié-Salpétrière)
name: Marc VERNY, Profesor
role: STUDY_CHAIR
affiliation: CH Poissy
name: Marc SOUID, Doctor
role: STUDY_CHAIR
affiliation: CH Poissy
name: Marie-Gabrielle CORD'HOMME, Doctor
role: STUDY_CHAIR
affiliation: CHU Rennes
name: Véronique JOYEUX, Doctor
role: STUDY_CHAIR
affiliation: CHU Rennes
name: Gwenaëlle SOST, Doctor
role: STUDY_CHAIR
affiliation: CH Saint-Nazaire
name: Dominique BESNIER, Doctor
role: STUDY_CHAIR
affiliation: CH Saint-Nazaire
name: Philippe LEROUX, Doctor
role: STUDY_CHAIR
affiliation: CH Sallanches
name: Philippe NICOUD, Doctor
role: STUDY_CHAIR
affiliation: CH Sallanches
name: Serge PAYRAUD, Doctor
role: STUDY_CHAIR
affiliation: CHU Strasbourg
name: Bruno MOULIN, Profesor
role: STUDY_CHAIR
affiliation: CHU Strasbourg
name: Georges KALTENBACH, Profesor
role: STUDY_CHAIR
affiliation: CH Vannes
name: Eric MICHEZ, Doctor
role: STUDY_CHAIR
affiliation: CH Vannes
name: Jean-Max GOLDFARB, Doctor
role: STUDY_CHAIR
affiliation: Dialysis center - Brest
name: Marie-Paule GUILLODO-HAMELET, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Clermont-Ferrand
name: Mohammed HADJ-ABDELKADER, Doctor
role: STUDY_CHAIR
affiliation: CHU Marseille
name: Elodie CRETEL-DURAND, Doctor
role: STUDY_CHAIR
affiliation: CHU Rennes
name: Pierre JOUANNY, Profesor
role: STUDY_CHAIR
affiliation: CHU Saint-Nazaire
name: Sylvie HILY, Doctor
role: STUDY_CHAIR
References: