Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Composite outcomes of survival status and persistence or resolution of cardiac abnormalities.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients aged 18 years and above diagnosed with sepsis admitted to Jimma University Medical Center during the study periods that are willing to participate and continue follow-up of their disease condition for at least one year.
排除标准
- •Patients with any kind of pre-existing established cardiac disease prior to their sepsis diagnosis and those who are not willing to participate or not willing to have follow-up of their disease condition for at least one year.
结局指标
主要结局
Composite outcomes of survival status and persistence or resolution of cardiac abnormalities.
时间窗: at first, third and sixth- months post discharge
Outcomes will be assessed at the first, third, and sixth months post-discharge, with evaluations focusing on the following parameters: * Persistence or resolution of cardiac abnormalities * Survival status (alive or deceased) * Functional capacity and quality of life using standardized tools (KCCS).
次要结局
- Composite outcomes of persistence or resolution of cardiac abnormalities, Survival status (alive or deceased) and functional capacity and quality of life using standardized tools (KCCS).(at sixth- months post discharge)
研究者
Kedir Negesso Tukeni
MD, Internist and cardiologist, PhD fellow in Medical Research, Cardiovascular Science
Jimma University