Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis

Sepsis Clinical Trial

Official title:

Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis: an Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258252
• Other study ID #: 20240201
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: March 15, 2026

Study information

• Verified date: June 2024
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiangchunling[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current project was designed to examine the effects of BCAA metabolic dysfunction on cardiac function in septic patients.

Description:

Patients with sepsis and with/without type 2 diabetes will be included. Patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. Peripheral blood plasma and PBMCs were separated by differential centrifugation: the concentration of BCAAs in serum and PBMCs; the expression of PBMCs BCAAs metabolic enzymes BCAT 1, BCKDH, and PP 2 Cm by WB; and the levels of AST, ALT, LDH, CK, and CK-MB

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with sepsis with or without type 2 diabetes

Exclusion Criteria:

• patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age younger than 18 years patients who cannot provide informed consent

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Effect of BCAAs metabolic dysfunction on cardiac function in sepsis
Effect of BCAAs metabolic dysfunction on cardiac function in sepsis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Sepsis induced cardiomyopathy	Diagnostic criteria for Sepsis induced cardiomyopathy, TroponinT > 0.01 ng/ml	up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary	Plasma levels of TroponinT	If multiple measurements is available during the first 7 days, the mean measurement will be used for analysis.	up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary	Plasma levels of type B natriuretic peptide	If multiple measurements is available during the first 7 days, the mean measurement will be used for analysis.	up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary	ejection fraction	If multiple measurements is available during the first 7 day, the mean measurement will be used for analysis.	up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary	Left ventricular and right ventricular size	If multiple measurements is available during the first 7 day, the mean measurement will be used for analysis.	up to 7 days post-ICU admission, or at hospital discharge, whichever comes first