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NCT Number: NCT07497139

Sepsis Induced Myocardial Injury in Critically Ill Children

Sepsis is a dysregulated immune response due to infection, leading to life-threatening organ dysfunction affecting respiratory, renal, immunological, digestive, neurological, and cardiovascular organs. The prevalence of cardiovascular dysfunction caused by sepsis may reach up to 50%, and the symptoms may comprise vasodilatory shock, myocardial injury, arrhythmia, and sepsis-induced cardiomyopathy. (1) Sepsis-induced cardiomyopathy occurs frequently in critically ill patients, but the clinical features and prognostic impact of sepsis-induced cardiomyopathy on sepsis outcome remain controversial.

Cardiac troponins I and T are regulatory proteins that control the calcium-mediated interaction of actin and myosin, producing myocardial contraction. Since troponins do not occur in extracellular space, their appearance in serum is sensitive and specific marker of myocardium damage. They have been established as the gold standard biochemical markers for myocardial necrosis .

Elevated cardiac troponins levels have been detected in critically ill children with congenital heart disease before and after cardiac surgery.(2) Echocardiography is the cornerstone for the diagnosis of septic cardiomyopathy. There is consensus and expert opinion that every hemodynamically unstable patient should receive critical care echocardiography.(3) Improved understanding of sepsis induced myocardial injury is important for multiple reasons. First, cardiac function is crucial for maintaining hemodynamic stability in patients with septic shock. Second, by understanding the clinical features and predictors of sepsis induced myocardial injury, the investigators can discriminate sepsis-induced cardiomyopathy from other cardiac diseases and avoid unnecessary invasive procedures, such as coronary angiography, a risky procedure in critically ill patients. Thus, the investigators aimed to define clinical predictors of sepsis-induced cardiomyopathy and assess the clinical course and outcome of sepsis-induced cardiomyopathy in patients with sepsis.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Improved understanding of sepsis induced myocardial injury is important for multiple reasons. First, cardiac function is crucial for maintaining hemodynamic stability in patients with septic shock. Second, by understanding the clinical features and predictors of sepsis induced myocardial injury, the investigators can discriminate sepsis-induced cardiomyopathy from other cardiac diseases and avoid unnecessary invasive procedures, such as coronary angiography, a risky procedure in critically ill patients. Thus, the investigators aimed to define clinical predictors of sepsis-induced cardiomyopathy and assess the clinical course and outcome of sepsis-induced cardiomyopathy in patients with sepsis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric population aged 1month to 18 years.
  • Critically ill children (who has an illness or injury impairing one or more vital organ systems such that there is high probability of imminent or life-threatening deterioration in the patient's condition)
  • Has clinically and laboratory manifestations of sepsis

Exclusion criteria

  • Neonates and adults ( <1 month or >18 years)
  • Children with congenital heart disease
  • Children with Acquired heart disease ( Rheumatic, Myocarditis or Cardiomyopathy)
  • Cardiac surgery

Treatment and study plan

observational study

Other

Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children

Primary outcomes

  1. Assessment of cardiac function critically ill children with sepsis

    Time frame: at day 1 of admission and day 5 to 7 after starting treatment

    measurement of ejection fraction and valvular affection as predictors of myocardial injury in critically ill children with sepsis

Secondary outcomes

  1. Evaluation of permanent cardiac affection post sepsis

    Time frame: after 3 months (day 90 of admission)

    Evaluation of ejection fraction and valvular affection post treatment of sever sepsis in critically ill patients

Study contacts

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

Noha Mostafa, MS degree in pediatrics

CONTACT

[email protected]

+201017565048

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children; A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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