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

NCT06258252 | Not Yet Recruiting

• 1 other identifier: 20240201
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Plasma levels of TroponinT

  up to 7 days post-ICU admission, or at hospital discharge, whichever comes first

• Plasma levels of type B natriuretic peptide

  up to 7 days post-ICU admission, or at hospital discharge, whichever comes first

• ejection fraction

  up to 7 days post-ICU admission, or at hospital discharge, whichever comes first

• Left ventricular and right ventricular size

  up to 7 days post-ICU admission, or at hospital discharge, whichever comes first

Study Arms (2)

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

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

Interventions

Effect of BCAAs metabolic dysfunction on cardiac function in sepsis OTHER

Effect of BCAAs metabolic dysfunction on cardiac function in sepsis

Patients who are diagnosed as sepsis, with type 2 diabetes.; Patients who are diagnosed as sepsis, without type 2 diabetes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sepsis

You may qualify if:

• \- patients diagnosed with sepsis with or without type 2 diabetes

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fengmin Luo, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: June 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share