Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00173706
Recruitment Status : Unknown
Verified August 2005 by National Taiwan University Hospital. Recruitment status was: Recruiting
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 submitted to hemodialysis.
Condition or disease
Cardiac ComplicationsSigns and SymptomsMuscle WeaknessAnemiaHypotension
Drug: L-Carnitine Injection
L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for beta-oxidation. A lack of carnitine in hemodialysis patients is caused by insufficient carnitine synthesis and particularly by the loss through dialytic membranes, leading in some patients to carnitine depletion with a relative increase of esterified forms. Many studies have shown that L-carnitine supplementation leads to improvements in several complications seen in uremic patients, including cardiac complications, impaired exercise and functional capacities, muscle symptoms, increased symptomatic intradialytic hypotension, and erythropoietin-resistant anemia, normalizing the reduced carnitine palmitoyl transferase activity in red cells.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with the following criteria will be eligible for participation in this study:
Male or female adults over 18 years of age
On hemodialysis for at least one year
Interdialysis weight gain < 5%
Bicarbonate dialysis 3 times per week
Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis)
Have one of the following symptoms and signs that have not responded to diet or pharmacological intervention:
Normal iron status (ferritin > 100 ng/ml; transferrin saturation [TSAT] > 20%)
Informed consent obtained
Patients with diabetes mellitus are allowed to enter the study if they have stable glycaemic control on diet or pharmacological treatment.
Patients displaying one or more of the following criteria will not be eligible for participation in this study:
Severe uncontrolled hypertension (systolic > 170; diastolic > 115) outside of dialysis
Some patients have echocardiogram (ECHO) defined chronic heart failure. Patients with New York Heart Association (NYHA) class II and class III can be admitted. Patients with class IV must be excluded. Some patients have angina. Patients with stable effort angina well controlled by treatment can be recruited. Absolute exclusion for angina at rest.
Major hepatic diseases - chronic active (aggressive) hepatitis or cirrhosis
Systemic haematological diseases and tumours
History of drug and alcohol abuse
Positive screening for HIV antibodies
Life expectancy of less than one year
Uncontrolled hyperparathyroidism (patients with stable bone status can be recruited)
Use of immunodepressants during the preceding 4 weeks
Changes in corticoid therapy in the preceding 4 weeks
Use of experimental drugs during the preceding 4 months
Use of L-carnitine during the preceding 4 months
Informed consent not obtained
Patients already included in other clinical trials.