Early Administration of L-Carnitine in Hemodialysis Patients

2014-08-27 03:44:54 | BioPortfolio


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.

Statistical analysis:

- 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

Study Design

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

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:44:54-0400

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Medical and Biotech [MESH] Definitions

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

A high-affinity, ATP-binding, co-transporter for CARNITINE that is highly expressed in kidney, skeletal muscle, heart, and placental tissues. It transports one sodium ion with one carnitine molecule. It has a lower affinity for other organic cations and transports them independently of sodium. Mutations in the SLC22A5 gene are associated with systemic carnitine deficiency.

The period of care beginning when the patient is removed from surgery and aimed at meeting the patient's psychological and physical needs directly after surgery. (From Dictionary of Health Services Management, 2d ed)

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

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