Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322322
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2006-05-03
Brief Title:
Early Administration of L-carnitine in Hemodialysis Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Early Administration of L-carnitine in Hemodialysis Patients Double Blind Randomized Trial Versus Placebo
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None