Sepsis and Myocarditis

NCT07079605 | Recruiting

• 1 other identifier: JUIH/IRB/278/25
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis-related Myocarditis

Keywords

Sepsis; myocarditis; mortality; survival analysis; low in-come countries; Ethiopia

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  at sixth- months post discharge

Study Arms (2)

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.

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.

Other: Treatment for the sepsis with standard management of cardiac failure

Interventions

Standard treatment for sepsis of any focus OTHER

This group of patients will be treated for the sepsis of any focus as per standard.

Group A

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include all adult septic patients admitted to JUMC during the study period.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jimma University: lead
• Ethiopian Society of Cardiac Professionals: collaborator

Study Sites (1)

Jimma University Hospital

Jimma, Oromiya, 378, Ethiopia

RECRUITING

Related Publications (8)

• 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.

  PMID: 17452940 RESULT

• Merx MW, Weber C. Sepsis and the heart. Circulation. 2007 Aug 14;116(7):793-802. doi: 10.1161/CIRCULATIONAHA.106.678359.

  PMID: 17698745 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.

  PMID: 37859613 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.

  PMID: 32506871 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.

  PMID: 36722388 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.

  PMID: 24171518 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.

  PMID: 34939034 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.

  PMID: 33680740 RESULT

MeSH Terms

Conditions

Sepsis; Myocarditis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nikolaus Alexander Haas, MD, Pediatician, Cardiologist

  Ludwig Maximillians University of Munich, Germany

  STUDY CHAIR

Central Study Contacts

Kedir Negesso Tukeni, MD, Internist, Cardiologist

CONTACT

0913521475; Kedir.negesso@ju.edu.et

Kidus Tesfaye Bezabih, MD, Internist

CONTACT

0920197780; kdstesfaye@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Internist and cardiologist, PhD fellow in Medical Research, Cardiovascular Science

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: May 9, 2025
• Primary Completion: May 8, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

ET (1)