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Starting soon Observational

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.

NCT07030114 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2026-04
Last updated
2025-06-22

Condition(s) studied

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

Investigational drug(s) / intervention(s)

complete blood testsmechanical ventilation (MV)

complete blood tests: 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): 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.

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis. — 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.

Trial sites (1)

FacilityCityRegionStatus
Assiut University Children's Hospital Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07030114 on ClinicalTrials.gov ↗ ← All trials in Egypt