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| Name | Class |
|---|---|
| Ethiopian Society of Cardiac Professionals | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | This is a group of patients with the diagnosis of sepsis of any focus but without any signs/symptoms suggestive of cardiac involvement. |
| |
| Group B | 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:
Both groups will be followed prospectively for 9 to 1 year to evaluate their outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment for sepsis of any focus | Other | This group of patients will be treated for the sepsis of any focus as per standard. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| at first, third and sixth- months post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all adult septic patients admitted to JUMC during the study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kedir Negesso Tukeni, MD, Internist, Cardiologist | Contact | 0913521475 | Kedir.negesso@ju.edu.et | |
| Kidus Tesfaye Bezabih, MD, Internist | Contact | 0920197780 | kdstesfaye@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaus Alexander Haas, MD, Pediatician, Cardiologist | Ludwig Maximillians University of Munich, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jimma University Hospital | Recruiting | Jimma | Oromiya | 378 | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17452940 | Result | Rudiger A, Singer M. Mechanisms of sepsis-induced cardiac dysfunction. Crit Care Med. 2007 Jun;35(6):1599-608. doi: 10.1097/01.CCM.0000266683.64081.02. | |
| 17698745 | Result | Merx MW, Weber C. Sepsis and the heart. Circulation. 2007 Aug 14;116(7):793-802. doi: 10.1161/CIRCULATIONAHA.106.678359. |
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The team is yet to decide whether to share IPD or not.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment for the sepsis with standard management of cardiac failure | Other | 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. |
|
| at sixth- months post discharge |
| 37859613 | Result | Song J, Fang X, Zhou K, Bao H, Li L. Sepsis-induced cardiac dysfunction and pathogenetic mechanisms (Review). Mol Med Rep. 2023 Dec;28(6):227. doi: 10.3892/mmr.2023.13114. Epub 2023 Oct 20. |
| 32506871 | Result | Habimana R, Choi I, Cho HJ, Kim D, Lee K, Jeong I. Sepsis-induced cardiac dysfunction: a review of pathophysiology. Acute Crit Care. 2020 May;35(2):57-66. doi: 10.4266/acc.2020.00248. Epub 2020 May 31. |
| 36722388 | Result | Jentzer JC, Lawler PR, Van Houten HK, Yao X, Kashani KB, Dunlay SM. Cardiovascular Events Among Survivors of Sepsis Hospitalization: A Retrospective Cohort Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e027813. doi: 10.1161/JAHA.122.027813. Epub 2023 Feb 1. |
| 24171518 | Result | Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available. |
| 34939034 | Result | Kwizera A, Urayeneza O, Mujyarugamba P, Baelani I, Meier J, Mer M, Musa N, Kissoon N, Patterson AJ, Farmer JC, Dunser MW. Epidemiology and Outcome of Sepsis in Adults and Children in a Rural, Sub-Sahara African Setting. Crit Care Explor. 2021 Dec 16;3(12):e0592. doi: 10.1097/CCE.0000000000000592. eCollection 2021 Dec. |
| 33680740 | Result | Mulatu HA, Bayisa T, Worku Y, Lazarus JJ, Woldeyes E, Bacha D, Taye B, Nigussie M, Gebeyehu H, Kebede A. Prevalence and outcome of sepsis and septic shock in intensive care units in Addis Ababa, Ethiopia: A prospective observational study. Afr J Emerg Med. 2021 Mar;11(1):188-195. doi: 10.1016/j.afjem.2020.10.001. Epub 2020 Nov 5. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |