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

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05673239

Collaborator

(none)

1,000

Enrollment

Arms

5.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Drug: Levocarnitine Injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group 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 The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day
No Intervention: Control group The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine.

Arm

Intervention/Treatment

Experimental: Test group

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

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

No Intervention: Control group

The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine.

Outcome Measures

Primary Outcome Measures

Change from baseline in Left ventricular ejection fraction [baseline and week 12]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;