Sepsis Induced Myocardial Injury in Critically Ill Children

NCT07497139 | Not Yet Recruiting DMC

• 1 other identifier: Sepsis Myocardial Injury
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Induced Cardiomyopathy; Sepsis Induced Myocardial Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of permanent cardiac affection post sepsis

  after 3 months (day 90 of admission)

Study Arms (1)

Sepsis induced myocardial injured children

Sepsis Induced Myocardial Injury In Critically Ill Children

Other: observational study

Interventions

observational study OTHER

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

Sepsis induced myocardial injured children

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Noha Mostafa, MS degree in pediatrics

CONTACT

+201017565048; nohamostafa2791994@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

EG (1)