Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 hemodialysis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital

Criteria

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.