Use of In-Line Filtration in Critically Ill Children

Phase 4

Completed

• Conditions: Critical Illness

• Registration Number: NCT00209768
• Lead Sponsor: Hannover Medical School

Brief Summary

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

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

1. Lung

2. Kidney

3. Liver

4. Circulation

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-11-28
• Last Update Posted: 2008-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 821

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sepsis
Thrombosis
SIRS
Organ failure
Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"

Secondary Outcome Measures

Name	Time	Method
Duration of overall hospital stay
Duration of Pediatric Intensive Care Unit stay

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Niedersachsen, Germany