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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173706
First received: September 12, 2005
Last updated: February 28, 2006
Last verified: August 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 40
Study Start Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173706

Contacts
Contact: Kwan-Dun Wu, Ph.D 886-2-23123456 ext 2117 kdw@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Kwan-Dun Wu, Ph.D    886-2-23123456 ext 2117    kdw@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Kwan-Dun Wu, Ph.D National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173706     History of Changes
Other Study ID Numbers: 930404
Study First Received: September 12, 2005
Last Updated: February 28, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
L-Carnitine
hemodialysis
cardiac complications
impaired exercise and functional capacities
muscle symptoms
intradialytic hypotension
erythropoietin-resistant anemia

Additional relevant MeSH terms:
Anemia
Asthenia
Hypotension
Muscle Weakness
Paresis
Signs and Symptoms
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014