Use of In-Line Filtration in Critically Ill Children

Hannover Medical School (MHH)

Status and phase

Completed

Phase 4

Conditions

Critical Illness

Treatments

Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00209768

3702

Details and patient eligibility

About

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).

Full 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