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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05673239
• Other study ID #: 2022-ZKNT-001
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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;

Related Conditions & MeSH terms

• Renal Dialysis

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