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 submitted to hemodialysis.

Study Overview

• Status: Unknown
• Conditions: Muscle Weakness; Anemia; Hypotension; Cardiac Complications; Signs and Symptoms
• Intervention / Treatment: Drug: L-Carnitine Injection

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 Type: Interventional
• Enrollment: 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kwan-Dun Wu, Ph.D; Phone Number: 2117 886-2-23123456; Email: kdw@ha.mc.ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Kwan-Dun Wu, Ph.D; Phone Number: 2117 886-2-23123456; Email: kdw@ha.mc.ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
weakness
improvement of hypotension and hematology profile
reduction of erythropoietin requirement
increase of plasma carnitine concentration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Kwan-Dun Wu, Ph.D, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): March 1, 2006
• Last Update Submitted That Met QC Criteria: February 28, 2006
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Keywords: hemodialysis; L-Carnitine; cardiac complications; impaired exercise and functional capacities; muscle symptoms; intradialytic hypotension; erythropoietin-resistant anemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Hypotension
• Other Study ID Numbers: 930404