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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Chunling Jiang, PhD; Phone Number: 18980601096; Email: jiangchunling@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with sepsis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who are diagnosed as sepsis, with type 2 diabetes.; 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.	Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis; Effect of BCAAs metabolic dysfunction on cardiac function in sepsis
Patients who are diagnosed as sepsis, without type 2 diabetes.; 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.	Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis; Effect of BCAAs metabolic dysfunction on cardiac function in sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Fengmin Luo, PhD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 20240201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No