Use of In-Line Filtration in Critically Ill Children
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|ClinicalTrials.gov Identifier: NCT00209768|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E||Phase 4|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||821 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Organ failure
- Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
- Duration of Pediatric Intensive Care Unit stay
- Duration of overall hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209768
|Hannover Medical School|
|Hannover, Niedersachsen, Germany, 30625|
|Study Director:||Michael Sasse, Consultant||Medical School Hannover|
|Principal Investigator:||Thomas Jack, Doctor||Medical School Hannover|