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

NCT00173706 | Unknown Phase 4

• 1 other identifier: 930404
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 hemodialysis.

Conditions

Cardiac Complications; Signs and Symptoms; Muscle Weakness; Anemia; Hypotension

Keywords

L-Carnitine; hemodialysis; cardiac complications; impaired exercise and functional capacities; muscle symptoms; intradialytic hypotension; erythropoietin-resistant anemia

Outcome Measures

Primary Outcomes (4)

• weakness

• improvement of hypotension and hematology profile

• reduction of erythropoietin requirement

• increase of plasma carnitine concentration

Secondary Outcomes (4)

• including all the components of the primary endpoints for their further assessment

• improvement of the nutritional indexes

• intradialytic complications (muscle symptoms, dyspnea, palpitations)

• quality of life

Interventions

L-Carnitine Injection DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Signs and Symptoms; Muscle Weakness; Anemia; Hypotension

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Kwan-Dun Wu, Ph.D

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Kwan-Dun Wu, Ph.D

CONTACT

886-2-23123456; kdw@ha.mc.ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2004
• Last Updated: March 1, 2006

Record last verified: 2005-08

Locations

TW (1)