Advertisement

Topics

Early Administration of L-Carnitine in Hemodialysis Patients

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

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.

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Patient Beginning Chronic Hemodialysis for Less Than 1 Month

Intervention

L-Carnitine

Location

HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Paris
France
75013

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

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

Clinical Trials [1389 Associated Clinical Trials listed on BioPortfolio]

Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis

This is a study designed to test the hypothesis that treatment with L-carnitine will improve the quality of life and some specific symptoms and signs in patients with renal failure submitt...

BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients

Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead to sleep apnea and poor sleep quality. We conduct this trial to evaluate whether more accurate ...

Effect of Acetyl-L-carnitine on Chronic Pancreatitis

An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory media...

Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin levels, may be associated with requirements for higher recombinant human erythropoietin doses a...

Impact on Functional Status in Older Adults Treated With L-Carnitine

This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, dis...

PubMed Articles [17234 Associated PubMed Articles listed on BioPortfolio]

The Unexpected Effects of L-Carnitine Supplementation on Lipid Metabolism in Hemodialysis Patients.

There is a growing body of evidence that the long-term hemodialysis (HD) treatment leads to disturbances of carnitine homeostasis but the results of L-carnitine supplementation in HD patients have bee...

SLC22A5 Mutations in a Patient With Systemic Primary Carnitine Deficiency and Cleft Palate-Successful Perioperative Management.

Primary systemic carnitine deficiency (SCD) is an autosomal-recessive disorder caused by SLC22A5 gene mutation resulting in defective cellular carnitine transporter organic cation transporter 2. Defec...

Decompensated Chronic Heart Failure Reduces Plasma L-carnitine.

The heart has an intense aerobic metabolism and is among the most metabolically active organs in the body. Its tissue stores fatty acid, the main energetic substrate, and requires high concentrations ...

Patient and treatment characteristics associated with patient activation in patients undergoing hemodialysis: a cross-sectional study.

Patient activation is associated with better outcomes and lower costs. Although the concept is widely investigated, little attention was given to patient activation and its predictors in patients unde...

Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial.

The use of L-carnitine has been proposed in haemodialysis (HD) when deficiency is present to improve anaemia resistant to erythropoietin stimulating agent, intradialytic hypotension or cardiac failure...

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 2.3.1.7.

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.

More From BioPortfolio on "Early Administration of L-Carnitine in Hemodialysis Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


Searches Linking to this Trial