An observational study in Sepsis-related Myocarditis, sponsored by Jimma University. Recruiting at 1 site in Ethiopia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Jimma University · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 226 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Jimma University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include all adult septic patients admitted to JUMC during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a group of patients with the diagnosis of sepsis of any focus but without any signs/symptoms suggestive of cardiac involvement.
Other: Standard treatment for sepsis of any focus
This is a cohort of patients with the diagnosis of sepsis of any foci and with the evidences of cardiac involvement defined as one or a combination of the following: * Clinical symptoms include chest pain, dyspnea, or arrhythmias. * Abnormal biomarkers, including troponins or BNP levels. * Evidence of cardiac dysfunction on ECG or echocardiography. Both groups will be followed prospectively for 9 to 1 year to evaluate their outcomes.
Other: Treatment for the sepsis with standard management of cardiac failure
This group of patients will be treated for the sepsis of any focus as per standard.
This group of patients will be treated for the sepsis and management of cardiac failure with additional supportive care cocktails based on the specific indication.
Composite outcomes of survival status and persistence or resolution of cardiac abnormalities.
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).
Time frame: at first, third and sixth- months post discharge
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).
Outcomes will be assessed at six 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).
Time frame: at sixth- months post discharge
Plan to share: Undecided — The team is yet to decide whether to share IPD or not.
Started May 2025 (actual). Primary completion is estimated for May 2026, 11 months after the start.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 11 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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