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Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.
The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month.
Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo.
Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein.
Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments.
- description of the cohort
- comparisons of each evaluated variables between the 2 treatments
- ANOVA study for repeated measurements from inclusion to month-12 for Hb / rHuEPO dose to compare the course of the ratio between each group in intention to treat analysis
- analysis of the ratio Hb / rHuEPO month by month and taking into account tempera withdrawal
Following analysis in both intention to treat and per protocol analysis:
- acylcarnitine / carnitine ratio by ANOVA for repeated data
- number of predialysis hypotension by Chi2 test
- number of red blood cells transfusion by Chi2 test
- SF-36 physical status by comparison of mean
- SF-36 total score by comparison of mean
- lipid profile by ANOVA for repeated data
- HbA1c by ANOVA for repeated data
- variables that influenced primary and secondary variables will be analyzed by multivariate analysis
- statistical study of clinical events per month
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Patient Beginning Chronic Hemodialysis for Less Than 1 Month
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Assistance Publique - Hôpitaux de Paris
Published on BioPortfolio: 2014-08-27T03:44:54-0400
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Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.
An enzyme that catalyzes the formation of O-acetylcarnitine from acetyl-CoA plus carnitine. EC 22.214.171.124.
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