Sepsis Induced Myocardial Injury in Critically Ill Children

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis Induced Myocardial Dysfunction; Sepsis Induced Cardiomyopathy
• Intervention / Treatment: Other: observational study

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Noha Mostafa, MS degree in pediatrics; Phone Number: +201017565048; Email: nohamostafa2791994@gmail.com

Study Locations

• Egypt
  • Asyut, Egypt
    • Assiut University
    • Contact: Noha Mostafa, MS degree in pediatrics; Phone Number: +201017565048; Email: nohamostafa2791994@gmail.com
    • Contact: Assiut University, MS degree in pediatrics; Phone Number: +201017565048; Email: nohamostafa2791994@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis induced myocardial injured children; Sepsis Induced Myocardial Injury In Critically Ill Children	Other: observational study; Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of cardiac function critically ill children with sepsis	measurement of ejection fraction and valvular affection as predictors of myocardial injury in critically ill children with sepsis	at day 1 of admission and day 5 to 7 after starting treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of permanent cardiac affection post sepsis	Evaluation of ejection fraction and valvular affection post treatment of sever sepsis in critically ill patients	after 3 months (day 90 of admission)

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods; Observation
• Other Study ID Numbers: Sepsis Myocardial Injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED