Complication of Hemodialysis, Hyperthyroidism Treated or Under Control
Conditions
Keywords
L-carnitine supplementation, Hemodialysis, Anaemia, Erythropoietin responsiveness
Brief summary
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
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
Interventions
DRUGL-Carnitine
L-Carnitine
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resistance index to erythropoietin | during de study | Resistance index to erythropoietin |
| Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. | during the study | Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predialysis hypotension per patient during the study, data collected monthly | during the study | Predialysis hypotension per patient during the study, data collected monthly |
| SF 36 physical and total score at inclusion and at the end of the study | during the study | SF 36 physical and total score at inclusion and at the end of the study |
| Lipid profile, measured quarterly | during the study | Lipid profile, measured quarterly |
| Acylcarnitine/carnitine ratio measured quarterly | during the study | Acylcarnitine/carnitine ratio measured quarterly |
| Albuminemia measured quarterly | during the study | Albuminemia measured quarterly |
| c reactive protein measured quarterly | during the study | c reactive protein measured quarterly |
| HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance | during the study | HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance |
| Number of red blood cells transfusion per patient during the study, data collected monthly | during the study | Number of red blood cells transfusion per patient during the study, data collected monthly |
Countries
France
Outcome results
None listed