Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients

Study Overview
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Brief Summary
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This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.

Official Title
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Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study

Conditions
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Renal Dialysis

Intervention / Treatment
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* Drug: Levocarnitine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maintenance hemodialysis patients; 18 years<80 years; Have clear consciousness and independent behavior ability; Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L. Exclusion Criteria: Acute cardiovascular and cerebrovascular diseases occurred within 1 month; Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant; Patients who have used L-carnitine within 2 weeks. Hematological system tumor or tumor;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form. | Drug: Levocarnitine Injection<br>* The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day<br>|
| No Intervention: Control group<br>The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Left ventricular ejection fraction |  | baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Brain natriuretic peptide level |  | baseline ,week 4 and week 12 | 
| Change from baseline in left ventricular short axis shortening rate |  | baseline and week 12 | 
| Change from baseline in stroke volume |  | baseline and week 12 | 
| Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods |  | baseline and week 12 | 
| Change from baseline in serum albumin |  | baseline and week 12 | 
| Change from baseline in upper arm circumference |  | baseline and week 12 | 
| Change from baseline in prealbumin |  | baseline and week 12 | 
| Change from baseline in hemoglobin |  | baseline and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Dialysis, Cardiac Function Tests, real-world study, multicenter, prospective, non-randomized, controlled