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

Primary Purpose

Cardiac Complications, Signs and Symptoms, Muscle Weakness

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
L-Carnitine Injection
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

weakness
improvement of hypotension and hematology profile
reduction of erythropoietin requirement
increase of plasma carnitine concentration

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
February 28, 2006
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00173706
Brief Title
Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Official Title
Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-Carnitine Injection
Primary Outcome Measure Information:
Title
weakness
Title
improvement of hypotension and hematology profile
Title
reduction of erythropoietin requirement
Title
increase of plasma carnitine concentration
Secondary Outcome Measure Information:
Title
including all the components of the primary endpoints for their further assessment
Title
improvement of the nutritional indexes
Title
intradialytic complications (muscle symptoms, dyspnea, palpitations)
Title
quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwan-Dun Wu, Ph.D
Phone
886-2-23123456
Ext
2117
Email
kdw@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Dun Wu, Ph.D
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwan-Dun Wu, Ph.D
Phone
886-2-23123456
Ext
2117
Email
kdw@ha.mc.ntu.edu.tw

12. IPD Sharing Statement

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

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