Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-28 @ 8:22 PM
Study NCT ID:
NCT07079605
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sepsis and Myocarditis
Sponsor:
Jimma University
Organization:
Study Overview
Official Title:
Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective cohort study aims to investigate the cardiac manifestations of sepsis and their influence on disease outcomes among adult patients at Jimma University Medical Center, Ethiopia, from May 2025 to May 2026. The research will include adults aged 18 and older with sepsis, categorizing them based on the presence or absence of cardiac involvement, which will be assessed through clinical symptoms, biomarkers, ECG, and echocardiographic findings. The study will evaluate the persistence of cardiac abnormalities, functional capacity, and survival over one year, utilizing structured data collection and advanced statistical methods, including survival analysis and regression techniques, to identify predictors of adverse outcomes.
Detailed Description:
Background: Sepsis is a major cause of morbidity and mortality worldwide, frequently associated with multi-organ dysfunction, including the heart. Cardiac manifestations of sepsis, such as myocardial dysfunction and arrhythmias, significantly impact outcomes, yet their long-term implications remain inadequately studied, particularly in resource-limited settings like Ethiopia.
Objective: The objective of this study is to evaluate the cardiac manifestations of sepsis and their association with disease outcomes among adult patients with sepsis at Jimma University Medical Centre of Ethiopia.
Methodology: This prospective cohort study will be conducted at JUMC over one-year period, starting from May 2025 to May 2026. The study will be done on adult patients with no prior history of cardiac problems (aged ≥18 years) diagnosed with sepsis (including bacterial meningitis), and then grouped based on the presence (Group A) or absence (Group B) of sepsis-associated cardiac manifestations. Cardiac involvement will be defined using clinical symptoms, biomarkers (troponin, BNP), or abnormal ECG and echocardiographic findings. Outcomes, including persistence of cardiac abnormalities, functional capacity and survival, will be assessed and compared among both groups after one year of follow-up. Data will be gathered using a structured checklist and analysed using updated version software. The Kaplan-Meier curve and the log-rank test will be used to describe the survival function. Independent predictors of poor outcome will be identified by Cox regression analysis, and the model assumption will be checked by Schoenfeld and Cox-Snell residuals. The 95% confidence interval of the hazard ratio with a corresponding p-value of 0.05 will be used to declare statistical significance.
Objective: The objective of this study is to evaluate the cardiac manifestations of sepsis and their association with disease outcomes among adult patients with sepsis at Jimma University Medical Centre of Ethiopia.
Methodology: This prospective cohort study will be conducted at JUMC over one-year period, starting from May 2025 to May 2026. The study will be done on adult patients with no prior history of cardiac problems (aged ≥18 years) diagnosed with sepsis (including bacterial meningitis), and then grouped based on the presence (Group A) or absence (Group B) of sepsis-associated cardiac manifestations. Cardiac involvement will be defined using clinical symptoms, biomarkers (troponin, BNP), or abnormal ECG and echocardiographic findings. Outcomes, including persistence of cardiac abnormalities, functional capacity and survival, will be assessed and compared among both groups after one year of follow-up. Data will be gathered using a structured checklist and analysed using updated version software. The Kaplan-Meier curve and the log-rank test will be used to describe the survival function. Independent predictors of poor outcome will be identified by Cox regression analysis, and the model assumption will be checked by Schoenfeld and Cox-Snell residuals. The 95% confidence interval of the hazard ratio with a corresponding p-value of 0.05 will be used to declare statistical significance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: