Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
Study NCT ID:
NCT00209768
Status:
COMPLETED
Last Update Posted:
2008-12-01
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of In-Line Filtration in Critically Ill Children
Sponsor:
Hannover Medical School
Organization:
Study Overview
Official Title:
Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: