Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
226 participants
OBSERVATIONAL
2025-05-09
2026-09-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Standard treatment for sepsis of any focus
This group of patients will be treated for the sepsis of any focus as per standard.
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:
* 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.
Treatment for the sepsis with standard management of cardiac failure
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.
Interventions
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Standard treatment for sepsis of any focus
This group of patients will be treated for the sepsis of any focus as per standard.
Treatment for the sepsis with standard management of cardiac failure
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ethiopian Society of Cardiac Professionals
UNKNOWN
Jimma University
OTHER
Responsible Party
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Kedir Negesso Tukeni
MD, Internist and cardiologist, PhD fellow in Medical Research, Cardiovascular Science
Principal Investigators
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Nikolaus Alexander Haas, MD, Pediatician, Cardiologist
Role: STUDY_CHAIR
Ludwig Maximillians University of Munich, Germany
Locations
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Jimma University Hospital
Jimma, Oromiya, Ethiopia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Merx MW, Weber C. Sepsis and the heart. Circulation. 2007 Aug 14;116(7):793-802. doi: 10.1161/CIRCULATIONAHA.106.678359.
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.
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.
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.
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.
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.
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.
Other Identifiers
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JUIH/IRB/278/25
Identifier Type: -
Identifier Source: org_study_id
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