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| autoid | 86 |
| crg_id | CRG120500024 |
| titleoftrial | Prevention by pravastatin of nutritional degradation in haemodialysis patients with chronic inflammation |
| acronymnoftrial | PREDEN |
| website | http://www.preden.fr |
| identificationno | |
| leadprefix | Prof |
| leadsurname | COMBE |
| leadgivennames | CHRISTIAN |
| leadposition | DIRECTOR OF DEPARTEMENT |
| leaddepartment | NEPHROLOGIE-HEMODIALYSE |
| leadorganisation | HOPITAL PELLEGRIN - CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX |
| leadaddress | Place Amelie Raba-Leon 33076 Bordeaux - France |
| leademail | christian.combe@chu-bordeaux.fr |
| leadphone | +33 556 79 55 37 |
| leadfax | +33 556 79 60 32 |
| leadsuffix | |
| contactprefix | Prof |
| contactsurname | COMBE |
| contactgivennames | CHRISTIAN |
| contactposition | DIRECTOR OF DEPARTEMENT |
| contactdepartment | NEPHROLOGIE-HEMODIALYSE |
| contactorganisation | HOPITAL PELLEGRIN - CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX |
| contactaddress | Place Am?lie Raba-L?on 33076 Bordeaux - France |
| contactemail | christian.combe@chu-bordeaux.fr |
| contactphone | +33 556 79 55 37 |
| contactfax | +33 556 79 60 32 |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | Centre Hospitalier Universitaire de Bordeaux |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | 01/2006 |
| actualstart | |
| proposedcompletiondate | 07/2008 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 16_20 |
| multi_national_study | no |
| countrycentres | France |
| researchquestion | Does pravastatin preserve lean mass in haemodialysis patients with inflammation-malnutrition chronic state? |
| study_status_recruitment | not_yet_recruiting |
| study_status_recruitment_follow | |
| healthcarecondition | chronic haemodialysis - malnutrition - inflammation without identified clinical source |
| intervention1 | pravastatin 20 mg/day during 1 month versus placebo |
| intervention2 | pravastatin 40 mg/day during 11 months versus placebo |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18 - 80 |
| totalrecruitment | 160 |
| inclusion | - patients on chronic haemodialysis for at least 3 month
- 18 < age < 80 years - serum albumin level < 40 g/L - chronic inflammation defined by C-Reactive Protein (CRP) range 10-50 mg/L twice for an interval > 1 month - no identifiable cause of inflammation - negative pregnancy test - patient\'s consent - patients with diabetes can be included |
| exclusion | Pregnant women or likely to be pregnant without oral contraception or in feeding period.
Severe comorbidities influencing vital prognosis within <1 year: - cancer other than skin cancer (except melanoma) - severe cardiovasculary diseases (myocardial infarction from less than 6 months, heart failure NYHA stage IV, occlusive arterial lower limb disease stages III and IV). Comorbidity likely to have a long standing detrimental effect on nutritional status: - severe digestive diseases such as Crohn\'s disease, haemorrhagic rectocolitis, caeliac disease or malabsorption - chronic inflammatory diseases, vasculitides, lupus, rheumatoid arthritis. All hepatic or biliary pathologies and/or hepatic biological abnormalities, in particular transaminases > 3x upper limit of normal (ULN). Treatments interfering with nutritional or inflammatory status (steroids, chronic NSAIDs). Current immunosuppressent treatment. Current treatment statin or in the last 3 months . Muscle enzyme (CPK, ASAT) activities > ULN. Treatment with fibrate. Patients without an adequate dialysis dose (weekly length dialysis < 12 h/week and/or Kt/V <1,2). |
| primaryoutcomes | Differences in lean body mass as assessed by Dual X-ray Absorptiometry after 1 year of treatment by pravastatin or placebo in haemodialysis patients with chronic inflammation
|
| secondaryoutcomes | - effects of pravastatin on markers of inflammation (in particular CRP), relations between inflammation-nutrition-metabolism
- mechanisms of the anti-inflammatory action of pravastatin - potential effect of pravastatin on reduction in mortality |
| reference | Combe C., Nardi H., Etude PREDEN : Prevention par la pravastatine de la degradation de l\'etat nutritionnel des patients hemodialysis presentant un etat inflammatoire chronique. Nephrologie & Therapeutique. 2005;1:75-76. |