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| Sponsor: | Hannover Medical School |
|---|---|
| Collaborators: |
Pall GmbH Medical B. Braun Melsungen AG |
| Information provided by: | Hannover Medical School |
| ClinicalTrials.gov Identifier: | NCT00209768 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Critical Illness |
Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children |
| Enrollment: | 821 |
| Study Start Date: | February 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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:
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:
Failure of one of the following organs/systems
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany, Niedersachsen | |
| Hannover Medical School | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Study Director: | Michael Sasse, Consultant | Medical School Hannover |
| Principal Investigator: | Thomas Jack, Doctor | Medical School Hannover |
More Information
| Study ID Numbers: | 3702 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00209768 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
pediatric intensive care critically ill children in-line filtration prospective randomized study complications |
sepsis SIRS thrombosis organ failure |
|
Disease Attributes Pathologic Processes Critical Illness |
