Pediatric Sepsis-induced Multiple Organ Dysfunction SyndromeNCT07030114
The Study Seeks to Determine Potential Correlations Between Ventilation and Hematological Alterations, Contributing to a Better Understanding of Its Physiological Effects and Optimizing Patient Management in Critical Care Settings.
An observational study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
The study seeks to determine potential correlations between ventilation and hematological alterations, contributing to a better understanding of its physiological effects and optimizing patient management in critical care settings. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome
- What is being tested?
- complete blood tests and mechanical ventilation (MV)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to May 2027
- 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: the study will take place in Pediatric Intensive Care Unit (PICU) of (Assiut University Children's Hospital) with Pediatric patients aged 1 month to 18 years and Diagnosis of sepsis
Who may be able to join
- 1- Pediatric patients aged 1 month to 18 years 2- Diagnosis of sepsis based on (Specify Criteria, e.g., Sepsis-3 criteria) 3- Requirement for invasive mechanical ventilation for at least 24 hours. 4- Patients admitted to the PICU during the study period. 5- Availability of complete hematological data before and during mechanical ventilation
Who cannot join
- 1- Patients with pre-existing hematological disorders (e.g., leukemia, aplastic anemia, congenital coagulopathies).
- 2- Patients who received a blood product transfusion within the 7 days before MV initiation or during it.
- 3- Patients with incomplete medical records or missing hematological data.
- 4- Patients discharged or deceased within 24 hours of mechanical ventilation initiation.
- 5- Patients who received Hematopoietic drugs during MV.
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 Children's Hospital
Asyut
Assiut University, Vice president of graduate stu, +2088 22080150, vp_grad@aun.edu.eg
About this study
Official title: Impact of Mechanical Ventilation on Hematological Parameters in Pediatric Patients With Sepsis
The study seeks to determine potential correlations between ventilation and hematological alterations, contributing to a better understanding of its physiological effects and optimizing patient management in critical care settings.
Read the detailed description
- Sepsis is a clinical disorder caused by a dysregulated host response to severe infection. Pediatric sepsis remains a major public health issue and a significant cause of morbidity and mortality despite the development of standardized treatment guidelines, universal immunization programs, and advanced intensive-care organ support techniques. Severe sepsis is responsible for > 8% of all pediatric intensive care unit (PICU) admissions and causes > 4.5 million childhood deaths worldwide per year.
- However, the clinical manifestations of these infections vary from minimal symptoms to multiple organ failure and death. The currently accepted definitions of sepsis, severe sepsis, and septic shock were developed and refined using different criteria to help identify, treat, and study patients with infections who are at higher risk of significant morbidity and mortality as it is responsible of 25% of deaths in children worldwide.
- The onset, progression and outcome of sepsis are frequently associated with coagulation abnormalities, and the excessive crosstalk between inflammation and coagulation plays a vital role in these pathogenesis, which includes dysfunction of clotting cascade process, anticoagulant and fibrinolytic systems, together with related endothelial damage. Sepsis-related coagulopathy can range in severity from mildly decreased platelet counts and prolonged clotting time, which are indicative of subclinical issues, to more severe coagulopathies such as disseminated intravascular coagulation (DIC). Classic coagulation laboratory tests, such as activated partial thromboplastin time (APTT), prothrombin time (PT), and platelet count, mainly indicate signs of consumption and impaired synthesis instead of ongoing coagulopathy and change slowly in the disease course .
- Mechanical ventilation (MV) is a common practice in pediatric intensive care units (PICUs). Its utilization rate, as reported in multicenter and prospective studies in heterogeneous cohorts, varies from 20% to 50% of the patients admitted to these units. Mechanical ventilation is a crucial intervention in pediatric intensive care units (PICUs), particularly for children with sepsis. Sepsis, a life-threatening condition resulting from an uncontrolled immune response to infection, often necessitates invasive mechanical ventilation (IMV) to manage respiratory failure and maintain adequate blood gas levels. The duration of mechanical ventilation can significantly impact patient outcomes, with prolonged use associated with increased risks of complications such as ventilator-associated pneumonia (VAP) and longer hospital stays.
- Accurate and early diagnosis is important to initiate effective treatment and improve the prognosis of sepsis. Therefore, a large number of biomarkers have been developed to diagnose sepsis. Unfortunately, none of these biomarkers exhibit a high degree of sensitivity and specificity. The most common of these markers is C-reactive protein (CRP), which is a major acute-phase reactant in infection and inflammation.
- CBC is an inexpensive, simple, routine, and repeatable test used to indicate the presence of infection. Leucocyte numbers and neutrophil ratios were the most commonly used indices for detecting infections. Recently, other CBC parameters, such as NLR and PLR, have been used in children and adult patients to identify inflammatory processes. These parameters are routinely measured in all patients admitted to the PICU.
- The collaboration between mechanical ventilation and hematological parameters in pediatric sepsis patients is an area that warrants thorough investigation. Hematological abnormalities, including anemia, thrombocytopenia, and coagulopathies, are prevalent in sepsis and can adversely affect patient outcomes. Understanding how MV influences these parameters is essential for optimizing treatment protocols and improving prognoses. Despite the high incidence of MV in Egyptian PICUs, there is a gap in research focusing on its impact on hematological profiles in this demographic. Addressing this gap could lead to enhanced clinical practices and better patient outcomes in pediatric sepsis care.
- Being tested
- complete blood tests, mechanical ventilation (MV)
- Keywords
- hematological changes, lab investigation, pediatric patients, sepsis, mechanical ventilation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood testsDiagnostic test
Complete Blood Count (CBC): Using automated hematology analyzers to measure various blood cell parameters.
- C-Reactive Protein (CRP): Quantitative analysis using immunoturbidimetric assay.
- Erythrocyte Sedimentation Rate (ESR): Measured using the Westergren method.
- Coagulation profile:
- Prothrombin Time (PT): Using thromboplastin reagents and automated coagulation analyzers.
- Activated Partial Thromboplastin Time (aPTT): Using phospholipid-based reagents and automated analyzers.
- International Normalized Ratio (INR): Calculated from PT results.
- Bleeding Time: Ivy method or template bleeding time.
- Liver function tests: Including ALT, AST, ALP, bilirubin using spectrophotometric methods.
- Kidney function tests: Creatinine and BUN using enzymatic methods.
mechanical ventilation (MV)Device
Mechanical Ventilation Parameters
- - Ventilation Mode: Ventilator settings will record modes such as volume-controlled ventilation or synchronized intermittent mandatory ventilation (SIMV), which deliver breaths based on patient needs.
- Tidal Volume: Measured in milliliters per kilogram of predicted body weight. Tidal volume settings aim to optimize oxygenation while minimizing lung injury risks by adhering to evidence-based limits (<6 mL/kg).
- Positive End-Expiratory Pressure (PEEP): PEEP levels will be recorded in cmH₂O to prevent alveolar collapse and improve oxygenation. Adjustments will balance oxygenation benefits with potential risks like reduced venous return or lung overdistension.
- Fraction of Inspired Oxygen (FiO₂): FiO₂ values will be documented as decimals, starting at 1.0 (100% oxygen) and adjusted downward based on patient oxygenation needs.
What is being measured
The primary outcome is the main question the study is designed to answer.
identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis.
The primary outcome of the study is to identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis. This includes assessing changes in blood parameters such as anemia, coagulation abnormalities, and inflammatory markers before and during mechanical ventilation.
Measured: Baseline
Secondary outcomes (1)
optimize patient management in critical care settings
optimize patient management in critical care settings by understanding the physiological effects of MV.
- ICU and hospital mortality rates
- Duration of mechanical ventilation in days
- Length of ICU and hospital stay in days
- Extubation success and reintubation rates
- Incidence of ventilator-associated pneumonia (VAP)
- Progression to acute respiratory distress syndrome (ARDS)
- Need for renal replacement therapy during ICU stay
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric Sepsis-induced Multiple Organ Dysfunction SyndromeStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Magdy Abdelazeem Ahmed, Assiut University
- Investigators
- Ismail lotfy mohamed, professor, Study chair, Assiut Universitymervat amin mahmoud, assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030114
- Sponsor's protocol ID
- hematology and MV in sepsis
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Horak J, Martinkova V, Radej J, Matejovic M. Back to Basics: Recognition of Sepsis with New Definition. J Clin Med. 2019 Nov 1;8(11):1838. doi: 10.3390/jcm8111838.
PubMed 31683991Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.
PubMed 32032273Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
PubMed 15636651Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465Fleischmann-Struzek C, Goldfarb DM, Schlattmann P, Schlapbach LJ, Reinhart K, Kissoon N. The global burden of paediatric and neonatal sepsis: a systematic review. Lancet Respir Med. 2018 Mar;6(3):223-230. doi: 10.1016/S2213-2600(18)30063-8.
PubMed 29508706
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mechanical Ventilation on Hematological Parameters in Pediatric Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07030114
- Acronym / sponsor ID
- hematology and MV in sepsis
- Keywords
- hematological changes, lab investigation, pediatric patients, sepsis, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Jun 2025 (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.
The study seeks to determine potential correlations between ventilation and hematological alterations, contributing to a better understanding of its physiological effects and optimizing patient management in critical care settings.
Detailed description
- Sepsis is a clinical disorder caused by a dysregulated host response to severe infection. Pediatric sepsis remains a major public health issue and a significant cause of morbidity and mortality despite the development of standardized treatment guidelines, universal immunization programs, and advanced intensive-care organ support techniques. Severe sepsis is responsible for > 8% of all pediatric intensive care unit (PICU) admissions and causes > 4.5 million childhood deaths worldwide per year.
- However, the clinical manifestations of these infections vary from minimal symptoms to multiple organ failure and death. The currently accepted definitions of sepsis, severe sepsis, and septic shock were developed and refined using different criteria to help identify, treat, and study patients with infections who are at higher risk of significant morbidity and mortality as it is responsible of 25% of deaths in children worldwide.
- The onset, progression and outcome of sepsis are frequently associated with coagulation abnormalities, and the excessive crosstalk between inflammation and coagulation plays a vital role in these pathogenesis, which includes dysfunction of clotting cascade process, anticoagulant and fibrinolytic systems, together with related endothelial damage. Sepsis-related coagulopathy can range in severity from mildly decreased platelet counts and prolonged clotting time, which are indicative of subclinical issues, to more severe coagulopathies such as disseminated intravascular coagulation (DIC). Classic coagulation laboratory tests, such as activated partial thromboplastin time (APTT), prothrombin time (PT), and platelet count, mainly indicate signs of consumption and impaired synthesis instead of ongoing coagulopathy and change slowly in the disease course .
- Mechanical ventilation (MV) is a common practice in pediatric intensive care units (PICUs). Its utilization rate, as reported in multicenter and prospective studies in heterogeneous cohorts, varies from 20% to 50% of the patients admitted to these units. Mechanical ventilation is a crucial intervention in pediatric intensive care units (PICUs), particularly for children with sepsis. Sepsis, a life-threatening condition resulting from an uncontrolled immune response to infection, often necessitates invasive mechanical ventilation (IMV) to manage respiratory failure and maintain adequate blood gas levels. The duration of mechanical ventilation can significantly impact patient outcomes, with prolonged use associated with increased risks of complications such as ventilator-associated pneumonia (VAP) and longer hospital stays.
- Accurate and early diagnosis is important to initiate effective treatment and improve the prognosis of sepsis. Therefore, a large number of biomarkers have been developed to diagnose sepsis. Unfortunately, none of these biomarkers exhibit a high degree of sensitivity and specificity. The most common of these markers is C-reactive protein (CRP), which is a major acute-phase reactant in infection and inflammation.
- CBC is an inexpensive, simple, routine, and repeatable test used to indicate the presence of infection. Leucocyte numbers and neutrophil ratios were the most commonly used indices for detecting infections. Recently, other CBC parameters, such as NLR and PLR, have been used in children and adult patients to identify inflammatory processes. These parameters are routinely measured in all patients admitted to the PICU.
- The collaboration between mechanical ventilation and hematological parameters in pediatric sepsis patients is an area that warrants thorough investigation. Hematological abnormalities, including anemia, thrombocytopenia, and coagulopathies, are prevalent in sepsis and can adversely affect patient outcomes. Understanding how MV influences these parameters is essential for optimizing treatment protocols and improving prognoses. Despite the high incidence of MV in Egyptian PICUs, there is a gap in research focusing on its impact on hematological profiles in this demographic. Addressing this gap could lead to enhanced clinical practices and better patient outcomes in pediatric sepsis care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- the study will take place in Pediatric Intensive Care Unit (PICU) of (Assiut University Children's Hospital) with Pediatric patients aged 1 month to 18 years and Diagnosis of sepsis
Key inclusion criteria (1 listed)
- 1- Pediatric patients aged 1 month to 18 years 2- Diagnosis of sepsis based on (Specify Criteria, e.g., Sepsis-3 criteria) 3- Requirement for invasive mechanical ventilation for at least 24 hours. 4- Patients admitted to the PICU during the study period. 5- Availability of complete hematological data before and during mechanical ventilation
Key exclusion criteria (5 listed)
- 1- Patients with pre-existing hematological disorders (e.g., leukemia, aplastic anemia, congenital coagulopathies).
- 2- Patients who received a blood product transfusion within the 7 days before MV initiation or during it.
- 3- Patients with incomplete medical records or missing hematological data.
- 4- Patients discharged or deceased within 24 hours of mechanical ventilation initiation.
- 5- Patients who received Hematopoietic drugs during MV.
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 |
|---|---|---|
| complete blood testsComplete Blood Count (CBC): Using automated hematology analyzers to measure various blood cell parameters. * C-Reactive Protein (CRP): Quantitative analysis using immunoturbidimetric assay. * Erythrocyte Sedimentation Rate (ESR): Measured using the Westergren method. * Coagulation profile: * Prothrombin Time (PT): Using thromboplastin reagents and automated coagulation analyzers. * Activated Partial Thromboplastin Time (aPTT): Using phospholipid-based reagents and automated analyzers. * International Normalized Ratio (INR): Calculated from PT results. * Bleeding Time: Ivy method or template bleeding time. * Liver function tests: Including ALT, AST, ALP, bilirubin using spectrophotometric methods. * Kidney function tests: Creatinine and BUN using enzymatic methods. | Diagnostic test | – |
| mechanical ventilation (MV)Mechanical Ventilation Parameters * - Ventilation Mode: Ventilator settings will record modes such as volume-controlled ventilation or synchronized intermittent mandatory ventilation (SIMV), which deliver breaths based on patient needs. * Tidal Volume: Measured in milliliters per kilogram of predicted body weight. Tidal volume settings aim to optimize oxygenation while minimizing lung injury risks by adhering to evidence-based limits (<6 mL/kg). * Positive End-Expiratory Pressure (PEEP): PEEP levels will be recorded in cmH₂O to prevent alveolar collapse and improve oxygenation. Adjustments will balance oxygenation benefits with potential risks like reduced venous return or lung overdistension. * Fraction of Inspired Oxygen (FiO₂): FiO₂ values will be documented as decimals, starting at 1.0 (100% oxygen) and adjusted downward based on patient oxygenation needs. | Device | – |
Primary outcome
identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis.
Time frame: Baseline
The primary outcome of the study is to identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis. This includes assessing changes in blood parameters such as anemia, coagulation abnormalities, and inflammatory markers before and during mechanical ventilation.
1 secondary outcome
optimize patient management in critical care settings
Time frame: Baseline
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 22 Jun 2025.
- Results publication: PubMed 31683991Horak J, Martinkova V, Radej J, Matejovic M. Back to Basics: Recognition of Sepsis with New Definition. J Clin Med. 2019 Nov 1;8(11):1838. doi: 10.3390/jcm8111838.
- Results publication: PubMed 32032273Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.
- Results publication: PubMed 15636651Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
- Results publication: PubMed 31954465Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
- Results publication: PubMed 29508706Fleischmann-Struzek C, Goldfarb DM, Schlattmann P, Schlapbach LJ, Reinhart K, Kissoon N. The global burden of paediatric and neonatal sepsis: a systematic review. Lancet Respir Med. 2018 Mar;6(3):223-230. doi: 10.1016/S2213-2600(18)30063-8.
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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.
Ismail lotfy mohamed, professor study chair
Assiut University
mervat amin mahmoud, assistant professor study director
Assiut University
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 Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome, 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 1 inclusion and 5 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 22 Jun 2025. 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 Abdelrahman magdy abdelazeem, master degree (0201061529987, abdomagdy316@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030114, which also lists 5 linked publications.
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 22 Jun 2025.