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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05673239
Other study ID # 2022-ZKNT-001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 15, 2023
Est. completion date June 30, 2023

Study information

Verified date January 2023
Source The First Affiliated Hospital of Zhejiang Chinese Medical University
Contact chao xu
Phone +86 15868845542
Email werner0920@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levocarnitine Injection
The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Left ventricular ejection fraction baseline and week 12
Secondary Change from baseline in Brain natriuretic peptide level baseline ,week 4 and week 12
Secondary Change from baseline in left ventricular short axis shortening rate baseline and week 12
Secondary Change from baseline in stroke volume baseline and week 12
Secondary 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
Secondary Change from baseline in serum albumin baseline and week 12
Secondary Change from baseline in upper arm circumference baseline and week 12
Secondary Change from baseline in prealbumin baseline and week 12
Secondary Change from baseline in hemoglobin baseline and week 12
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