Use of In-Line Filtration in Critically Ill Children

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of in-line filtration shows any effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis, or organ failure in critically ill children admitted to the pediatric intensive care unit (PICU).

Detailed Description
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Scientific background: Particulate contamination of infusion solutions and their systemic administration during infusion therapy has been linked to various clinical problems. Organ failure and Multi-Organ Failure (MOV): It is well established that the pathophysiology of MOV involves deteriorations of the microcirculation and integrity of endothelial cells. As a consequence of this an imbalance between pro- and anticoagulatory factors may develop and microthrombi may form. Mediators like tissue factor (TF) and platelet activating factor (PAF) have been linked to the formation of microthrombi. Particles have been discussed as a causative agent for this syndrome by various authors. Their effect on morbidity and mortality of patients has however not yet been established. Particles may have additional harmful effects: Direct thrombogenesis by the particle material Damaging endothelial cells in the capillary network Embolisation of the pulmonary vasculature Acting as a cristallisation focus for the development of granuloma Promoting the formation of Giant Cells Various authors have shown that the use of end line infusion filters significantly reduces the rate of thrombophlebitis. A recently published study by van Lingen et al. (2004) also showed that the use of end line infusion filters significantly reduced the rate of overall complications in neonates. Study Hypothesis: The use of end line positively charged 0.2 µm and uncharged 1.2 µm infusion filters will prevent particles, microorganisms and their endotoxins from the infusate to enter the patient's circulation in the study group and will reduce significantly the complication rate of these patients. The following clinical diagnoses are defined as Complications. They are main contributors to morbidity and mortality in intensive care wards: catheter related thrombosis of the central veins sepsis with proven infectious organisms Septic syndrome without proven infectious organisms Failure of one of the following organs/systems Lung Kidney Liver Circulation

Official Title
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Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children admitted to pediatric intensive care unit (PICU) Exclusion Criteria: Suspected death within 48 hours Duration of PICU stay less than 6 hours Patients recruited for Simulect or Sintra Study

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis |  |  | 
| Thrombosis |  |  | 
| SIRS |  |  | 
| Organ failure |  |  | 
| Composite primary outcome including sepsis, SIRS, thrombosis, organ failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Pediatric Intensive Care Unit stay |  |  | 
| Duration of overall hospital stay |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric intensive care, critically ill children, in-line filtration, prospective randomized study, complications, sepsis, SIRS, thrombosis, organ failure