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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Carnitine Injection | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| weakness | ||
| improvement of hypotension and hematology profile | ||
| reduction of erythropoietin requirement | ||
| increase of plasma carnitine concentration |
| Measure | Description | Time Frame |
|---|---|---|
| including all the components of the primary endpoints for their further assessment | ||
| improvement of the nutritional indexes | ||
| intradialytic complications (muscle symptoms, dyspnea, palpitations) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwan-Dun Wu, Ph.D | Contact | 886-2-23123456 | 2117 | kdw@ha.mc.ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Kwan-Dun Wu, Ph.D | National Taiwan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D018908 | Muscle Weakness |
| D000740 | Anemia |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| quality of life |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |