Sepsis Induced CardiomyopathyNCT07497139
Sepsis Induced Myocardial Injury in Critically Ill Children
An observational study of Sepsis Induced Cardiomyopathy and Sepsis Induced Myocardial Dysfunction, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Sepsis Induced Cardiomyopathy, Sepsis Induced Myocardial Dysfunction
- What is being tested?
- observational study
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Neonates and adults ( <1 month or >18 years)
- Children with congenital heart disease
- Children with Acquired heart disease ( Rheumatic, Myocarditis or Cardiomyopathy)
- Cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut
Assiut University, MS degree in pediatrics, +201017565048, nohamostafa2791994@gmail.com
Noha Mostafa, MS degree in pediatrics, +201017565048, nohamostafa2791994@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children
| Study group | Role | What they receive |
|---|---|---|
| Sepsis induced myocardial injured children | Sepsis Induced Myocardial Injury In Critically Ill Children Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1 of admission and day 5 to 7 after starting treatment
Secondary outcomes (1)
Evaluation of permanent cardiac affection post sepsis
Evaluation of ejection fraction and valvular affection post treatment of sever sepsis in critically ill patients
Measured: after 3 months (day 90 of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mostafa Sayed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497139
- Sponsor's protocol ID
- Sepsis Myocardial Injury
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children; A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07497139
- Acronym / sponsor ID
- Sepsis Myocardial Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis induced myocardial injured children | – | Other: observational studySepsis Induced Myocardial Injury In Critically Ill Children |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Neonates and adults ( <1 month or >18 years)
- Children with congenital heart disease
- Children with Acquired heart disease ( Rheumatic, Myocarditis or Cardiomyopathy)
- Cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyPredictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children | Other | Sepsis induced myocardial injured children |
Primary outcome
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
1 secondary outcome
Evaluation of permanent cardiac affection post sepsis
Time frame: after 3 months (day 90 of admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock
Sepsis-induced Cardiomyopathy, the Recovery Phase of Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Induced Cardiomyopathy and Sepsis Induced Myocardial Dysfunction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Mostafa, MS degree in pediatrics (+201017565048, nohamostafa2791994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cardiac function critically ill children with sepsis (time frame: at day 1 of admission and day 5 to 7 after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.