Sepsis-related MyocarditisNCT07079605
Sepsis and Myocarditis
An observational study of Sepsis-related Myocarditis, run by Jimma University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis-related Myocarditis
- What is being tested?
- Standard treatment for sepsis of any focus and Treatment for the sepsis with standard management of cardiac failure
- How many people
- 226 participants
- Where
- 1 siteEthiopia
- Study dates
- 9 May 2025to 22 Sep 2026
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will include all adult septic patients admitted to JUMC during the study period.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma University Hospital
Jimma, Oromiya, 378
Kedir N Tukeni, MD, Internist, cardiologist, 0913521475, Kedir.negesso@ju.edu.et
Kidus T Bezabih, MD, Internist, 0920197780, kdstesfaye@gmail.com
About this study
Official title: Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Sepsis-related Myocarditis
- Being tested
- Standard treatment for sepsis of any focus, Treatment for the sepsis with standard management of cardiac failure
- Keywords
- Sepsis, myocarditis, mortality, survival analysis, low in-come countries, Ethiopia
- Medical subject headings
- Sepsis, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment for sepsis of any focusOther
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 failureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard treatment for sepsis of any focus | |
| 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. Receives: Other: Treatment for the sepsis with standard management of cardiac failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at first, third and sixth- months post discharge
Secondary outcomes (1)
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).
Measured: at sixth- months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start9 May 2025
- Primary completion8 May 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sepsis-related MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Society of Cardiac Professionals
- Responsible party
- Principal investigator, Kedir Negesso Tukeni, Jimma University
- Investigators
- Nikolaus Alexander Haas, MD, Pediatician, Cardiologist, Study chair, Ludwig Maximillians University of Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079605
- Sponsor's protocol ID
- JUIH/IRB/278/25
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The team is yet to decide whether to share IPD or not.
Publications
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.
PubMed 17452940Merx MW, Weber C. Sepsis and the heart. Circulation. 2007 Aug 14;116(7):793-802. doi: 10.1161/CIRCULATIONAHA.106.678359.
PubMed 17698745Song 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.
PubMed 37859613Habimana 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.
PubMed 32506871Jentzer 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.
PubMed 36722388Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
PubMed 24171518Kwizera 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.
PubMed 34939034Mulatu 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.
PubMed 33680740
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07079605
- Acronym / sponsor ID
- JUIH/IRB/278/25
- Conditions
- Sepsis-related Myocarditis
- Keywords
- Sepsis, myocarditis, mortality, survival analysis, low in-come countries, Ethiopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Ethiopian Society of Cardiac Professionals
- Study start
- 9 May 2025 (actual)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Standard treatment for sepsis of any focusThis is a group of patients with the diagnosis of sepsis of any focus but without any signs/symptoms suggestive of cardiac involvement. |
| Group B | – | Other: Treatment for the sepsis with standard management of cardiac failureThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include all adult septic patients admitted to JUMC during the study period.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment for sepsis of any focusThis group of patients will be treated for the sepsis of any focus as per standard. | Other | Group A |
| Treatment for the sepsis with standard management of cardiac failureThis group of patients will be treated for the sepsis and management of cardiac failure with additional supportive care cocktails based on the specific indication. | Other | Group B |
Primary outcome
Composite outcomes of survival status and persistence or resolution of cardiac abnormalities.
Time frame: 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).
1 secondary outcome
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).
Time frame: at sixth- months post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 17452940Rudiger 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.
- Results publication: PubMed 17698745Merx MW, Weber C. Sepsis and the heart. Circulation. 2007 Aug 14;116(7):793-802. doi: 10.1161/CIRCULATIONAHA.106.678359.
- Results publication: PubMed 37859613Song 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.
- Results publication: PubMed 32506871Habimana 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.
- Results publication: PubMed 36722388Jentzer 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.
- Results publication: PubMed 24171518Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
- Results publication: PubMed 34939034Kwizera 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.
- Results publication: PubMed 33680740Mulatu 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.
- Individual participant dataSharing planned: Undecided. The team is yet to decide whether to share IPD or not.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaus Alexander Haas, MD, Pediatician, Cardiologist study chair
Ludwig Maximillians University of Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis-related Myocarditis, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kedir Negesso Tukeni, MD, Internist, Cardiologist (0913521475, Kedir.negesso@ju.edu.et), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes of survival status and persistence or resolution of cardiac abnormalities. (time frame: at first, third and sixth- months post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079605, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.