Status:
UNKNOWN
Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Cardiac Complications
Signs and Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hemodi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00173706
Start Date
October 1 2004
Last Update
March 1 2006
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 110