Cardiac Complications | Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Cardiac Complications research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Signs and Symptoms
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2004
Phase: Phase 4
Primary Outcome: weakness
Secondary Outcome: including all the components of the primary endpoints for their further assessment
Study sponsors, principal investigator, and references
Principal Investigator: Kwan-Dun Wu, Ph.D
Lead Sponsor: National Taiwan University Hospital