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Not yet recruiting NCT07030114

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.

Observational Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: complete blood tests, mechanical ventilation (MV).
Who it may be relevant to
Registry conditions: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Mechanical Ventilation on Hematological Parameters in Pediatric Patients With Sepsis

Overview

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.

Interventions

  • Diagnostic test 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. * Interna
  • Device 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

Primary outcome measures

  • identify correlations between mechanical ventilation and hematological alterations in pediatric patients diagnosed with sepsis. [Time frame: Baseline]
Secondary outcome measures (1)
  • optimize patient management in critical care settings [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University Children's Hospital — Asyut

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. PMID 31683991
  • 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, N PMID 32032273
  • 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
  • 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. Lanc PMID 31954465
  • 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

Identifiers

NCT: NCT07030114 · hematology and MV in sepsis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗