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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00173706

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
Cardiac Complications Signs and Symptoms Muscle Weakness Anemia Hypotension	Drug: L-Carnitine Injection	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

weakness []
improvement of hypotension and hematology profile []
reduction of erythropoietin requirement []
increase of plasma carnitine concentration []

Secondary Outcome Measures

including all the components of the primary endpoints for their further assessment []
improvement of the nutritional indexes []
intradialytic complications (muscle symptoms, dyspnea, palpitations) []
quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:
persistent weakness affecting daily life
malnutrition
anemia (hemoglobin [Hb] < 12 g/dl; hematocrit [Hct] < 30%)
experiencing intradialytic complications (cramping, muscular pain, hypotension, hypertension, head-ache)
On regular treatment with vitamin B12 and folates
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.

Exclusion Criteria:

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
Uncontrollable diabetes
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
Pregnancy
Patients already included in other clinical trials.