Early Administration of L-carnitine in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

Conditions
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Complication of Hemodialysis, Hyperthyroidism Treated or Under Control

Intervention / Treatment
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* Drug: L-Carnitine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with less than 1 month on hemodialysis. Treated with rHuEPO. Male or female aged of more than 18 years old. With contraception treatment for women of procreation age. Having received and understand information. Exclusion Criteria: Patients with no need of rHuEPO Patients with cancer disease Patients with life expectancy under 6 months Patients having a proved carnitine deficiency before the start of hemodialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>L-Carnitine | Drug: L-Carnitine<br>* L-Carnitine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance index to erythropoietin | Resistance index to erythropoietin | during de study | 
| Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. | Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acylcarnitine/carnitine ratio measured quarterly | Acylcarnitine/carnitine ratio measured quarterly | during the study | 
| Number of red blood cells transfusion per patient during the study, data collected monthly | Number of red blood cells transfusion per patient during the study, data collected monthly | during the study | 
| Predialysis hypotension per patient during the study, data collected monthly | Predialysis hypotension per patient during the study, data collected monthly | during the study | 
| SF 36 physical and total score at inclusion and at the end of the study | SF 36 physical and total score at inclusion and at the end of the study | during the study | 
| Lipid profile, measured quarterly | Lipid profile, measured quarterly | during the study | 
| HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance | HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance | during the study | 
| Albuminemia measured quarterly | Albuminemia measured quarterly | during the study | 
| c reactive protein measured quarterly | c reactive protein measured quarterly | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness