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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. Identifier: NCT00173706
Recruitment Status : Unknown
Verified August 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : March 1, 2006
Information provided by:
National Taiwan University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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 : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Primary Outcome Measures :
  1. weakness
  2. improvement of hypotension and hematology profile
  3. reduction of erythropoietin requirement
  4. increase of plasma carnitine concentration

Secondary Outcome Measures :
  1. including all the components of the primary endpoints for their further assessment
  2. improvement of the nutritional indexes
  3. intradialytic complications (muscle symptoms, dyspnea, palpitations)
  4. quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with the following criteria will be eligible for participation in this study:

  1. Male or female adults over 18 years of age
  2. On hemodialysis for at least one year
  3. Interdialysis weight gain < 5%
  4. Bicarbonate dialysis 3 times per week
  5. Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis)
  6. Have one of the following symptoms and signs that have not responded to diet or pharmacological intervention:

    1. persistent weakness affecting daily life
    2. malnutrition
    3. anemia (hemoglobin [Hb] < 12 g/dl; hematocrit [Hct] < 30%)
    4. experiencing intradialytic complications (cramping, muscular pain, hypotension, hypertension, head-ache)
  7. On regular treatment with vitamin B12 and folates
  8. Normal iron status (ferritin > 100 ng/ml; transferrin saturation [TSAT] > 20%)
  9. Informed consent obtained
  10. 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:

  1. Severe uncontrolled hypertension (systolic > 170; diastolic > 115) outside of dialysis
  2. 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.
  3. Major hepatic diseases - chronic active (aggressive) hepatitis or cirrhosis
  4. Systemic haematological diseases and tumours
  5. Uncontrollable diabetes
  6. History of drug and alcohol abuse
  7. Positive screening for HIV antibodies
  8. Life expectancy of less than one year
  9. Uncontrolled hyperparathyroidism (patients with stable bone status can be recruited)
  10. Use of immunodepressants during the preceding 4 weeks
  11. Changes in corticoid therapy in the preceding 4 weeks
  12. Use of experimental drugs during the preceding 4 months
  13. Use of L-carnitine during the preceding 4 months
  14. Informed consent not obtained
  15. Pregnancy
  16. Patients already included in other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00173706

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Contact: Kwan-Dun Wu, Ph.D 886-2-23123456 ext 2117

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Kwan-Dun Wu, Ph.D    886-2-23123456 ext 2117   
Sponsors and Collaborators
National Taiwan University Hospital
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Study Director: Kwan-Dun Wu, Ph.D National Taiwan University Hospital
Layout table for additonal information Identifier: NCT00173706    
Other Study ID Numbers: 930404
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 1, 2006
Last Verified: August 2005
Keywords provided by National Taiwan University Hospital:
cardiac complications
impaired exercise and functional capacities
muscle symptoms
intradialytic hypotension
erythropoietin-resistant anemia
Additional relevant MeSH terms:
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Muscle Weakness
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes