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Sepsis Induced Myocardial Injury in Critically Ill Children

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07497139
Enrollment
84
Registered
2026-03-27
Start date
2026-04-01
Completion date
2028-04-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Induced Cardiomyopathy, Sepsis Induced Myocardial Dysfunction

Brief summary

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.

Detailed description

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.

Interventions

OTHERobservational study

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Pediatric population aged 1month to 18 years. 2. 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) 3. Has clinically and laboratory manifestations of sepsis

Exclusion criteria

1. Neonates and adults ( \<1 month or \>18 years) 2. Children with congenital heart disease 3. Children with Acquired heart disease ( Rheumatic, Myocarditis or Cardiomyopathy) 4. Cardiac surgery

Design outcomes

Primary

MeasureTime frameDescription
Assessment of cardiac function critically ill children with sepsisat day 1 of admission and day 5 to 7 after starting treatmentmeasurement of ejection fraction and valvular affection as predictors of myocardial injury in critically ill children with sepsis

Secondary

MeasureTime frameDescription
Evaluation of permanent cardiac affection post sepsisafter 3 months (day 90 of admission)Evaluation of ejection fraction and valvular affection post treatment of sever sepsis in critically ill patients

Countries

Egypt

Contacts

CONTACTNoha Mostafa, MS degree in pediatrics
nohamostafa2791994@gmail.com+201017565048

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026