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 | Not Yet Recruiting

• 1 other identifier: hematology and MV in sepsis
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

Keywords

hematological changes; lab investigation; pediatric patients; sepsis; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• optimize patient management in critical care settings

  Baseline

Interventions

complete blood tests DIAGNOSTIC_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.

Eligibility Criteria

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

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

You may qualify if:

• 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

You may not qualify if:

• Patients with pre-existing hematological disorders (e.g., leukemia, aplastic anemia, congenital coagulopathies).
• Patients who received a blood product transfusion within the 7 days before MV initiation or during it.
• Patients with incomplete medical records or missing hematological data.
• Patients discharged or deceased within 24 hours of mechanical ventilation initiation.
• Patients who received Hematopoietic drugs during MV.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Children's Hospital

Asyut, Egypt

Location

Related Publications (5)

• 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.

  PMID: 31683991 BACKGROUND

• Weiss 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.

  PMID: 32032273 BACKGROUND

• Goldstein 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.

  PMID: 15636651 BACKGROUND

• Rudd 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.

  PMID: 31954465 BACKGROUND

• Fleischmann-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.

  PMID: 29508706 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Ismail lotfy mohamed, professor

  Assiut University

  STUDY CHAIR

• mervat amin mahmoud, assistant professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman magdy abdelazeem, master degree

CONTACT

0201061529987; abdomagdy316@gmail.com

Ismail Lotfy Mohamed, Professor

CONTACT

0201063398967; ismail231@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-05

Locations

EG (1)