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NCT Number: NCT07079605

Sepsis and Myocarditis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jimma University Hospital

Jimma, Oromiya, 378, Ethiopia

Location status: Recruiting

Location contact

Elsah T Asefa, MD, cardiologist

SUB_INVESTIGATOR

Esayas K Gudina, MD, Internist

SUB_INVESTIGATOR

Kedir N Tukeni, MD, Internist, cardiologist

CONTACT

[email protected]

0913521475

Kidus T Bezabih, MD, Internist

CONTACT

[email protected]

0920197780

Mohammed M Abafogi, MD, cardiologist

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Standard treatment for sepsis of any focus

Other

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

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.

Primary outcomes

  1. 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).

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).

    Time frame: at sixth- months post discharge

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kedir Negesso Tukeni, MD, Internist, Cardiologist

CONTACT

[email protected]

0913521475

Kidus Tesfaye Bezabih, MD, Internist

CONTACT

[email protected]

0920197780

Sponsors and collaborators

Lead sponsor

Jimma University

Other

Collaborators

  • Ethiopian Society of Cardiac Professionals

Registry information

Official study title

Cardiac Manifestations of Sepsis and Its Association With Disease Outcome: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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