Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

Study Overview
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Brief Summary
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OBJECTIVES To assess the levels of plasma carnitine in controls and hemodialysis patients. To give supplementary L-carnitine to study subjects for a duration of 5months. To compare the values of plasma carnitine before and after L carnitine supplementation. To assess the role of carnitine supplementation on biochemical and clinical parameters.

Detailed Description
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.ABSTRACT INTRODUCTION Dialysis therapy can cause a decrease in both free carnitine and plasma acyl carnitines after only six months of dialysis treatment. A positive correlation between AC/FC ratio and months on HD therapy has been reported. We investigate in this study the role of oral L-carnitine supplementation on anemia, blood pressure, cardiac dysfunction and muscle cramps in hemodialysis patients. OBJECTIVES To assess the levels of plasma carnitine in controls and hemodialysis patients. To give supplementary L-carnitine to study subjects for a duration of 5months. To compare the values of plasma carnitine before and after L carnitine supplementation. To assess the role of carnitine supplementation on biochemical and clinical parameters. STUDY DESIGN AND SETTING: It will be a case-control study, which will be conducted in the Department of Biochemistry, University of Karachi in collaboration with Nephrology ward of JPMC, Karachi in a period of one year after approval of synopsis. METHOD: Total 120 subjects will be included in this study which will be divided into two groups. Group A will comprise of 60 subjects of Chronic renal failure who will be the control group. Group B will comprise of 60 subjects who will be on hemodialysis for more than 1 year. Blood samples will be taken after informed consent. Group B subjects will be given L-Carnitine supplementation for five months under strict monitoring. Physical, biochemical and clinical parameters of group B subjects will be compared before and after supplementation. RESULTS: Data will be analyzed using SPSS version 21. Results will be shared after completion of research. CONCLUSION: conclusion will be shared after completion of research.

Official Title
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Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

Conditions
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Hemodialysis Complication

Intervention / Treatment
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* Drug: L-Carnitine 500Mg thrice daily
* Drug: 1g L-Carnitine IV three times a week


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Individuals of either sex (male and female). The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants. Exclusion Criteria: • Individuals with any other chronic ailment, such as cancer or tuberculosis. Patients with acute renal failure who are receiving hemodialysis. All subjects who refused to take part in the investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects of group B oral intervention group were given oral L-carnitine supplementation in the form of L-Carnitine tablets 500 mg thrice daily under strict monitoring for 5 months. The vitals were monitored daily during the course of supplementation. Subjects of group B intravenous group were given Intra venous L-Carnitine as a dose of 20mg/kg IV bolus infused over 2-3 minutes, administered into intra venous line after every hemodialysis session ( thrice a week) for 5 months. Complete general physical examination was done on every dialysis session. Patients were strictly monitored for the development of any signs of distress during the course of supplementation the drug. The patients and their attendants were educated about monitoring the vitals at home daily and to inform nephrologist immediately in case of any signs of allergy or distress. The supplementation was given after obtaining ethical approval and informed consent and under direct supervision of a Nephrologist.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>L-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week | Drug: L-Carnitine 500Mg thrice daily<br>* L-Carnitine 500mg oral thrice daily<br>Drug: 1g L-Carnitine IV three times a week<br>* 1g IV L-Carnitine three times a week<br>|
| No Intervention: control<br>no intervention given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L-Carnitine levels in hemodialysis | plasma carnitine will be detected before and after giving intervention (unit μmol/L) | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, L-Carnitine, chronic kidney disease