Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Cardiac Complications, Signs and Symptoms, Muscle Weakness
About this trial
This is an interventional treatment trial for Cardiac Complications focused on measuring L-Carnitine, hemodialysis, cardiac complications, impaired exercise and functional capacities, muscle symptoms, intradialytic hypotension, erythropoietin-resistant anemia
Eligibility Criteria
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: 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 Criteria: 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.
Sites / Locations
- National Taiwan University HospitalRecruiting