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| Name | Class |
|---|---|
| Pall Corporation | OTHER |
| B. Braun Melsungen AG | INDUSTRY |
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).
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:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filter: NOE96E, ELD96E, NLF1E, TNA1E | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis | ||
| Thrombosis | ||
| SIRS | ||
| Organ failure | ||
| Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure" |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Pediatric Intensive Care Unit stay | ||
| Duration of overall hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Sasse, Consultant | Medical School Hannover | Study Director |
| Thomas Jack, Doctor | Medical School Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29544449 | Derived | Lamping F, Jack T, Rubsamen N, Sasse M, Beerbaum P, Mikolajczyk RT, Boehne M, Karch A. Development and validation of a diagnostic model for early differentiation of sepsis and non-infectious SIRS in critically ill children - a data-driven approach using machine-learning algorithms. BMC Pediatr. 2018 Mar 15;18(1):112. doi: 10.1186/s12887-018-1082-2. | |
| 23384207 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| Boehne M, Jack T, Koditz H, Seidemann K, Schmidt F, Abura M, Bertram H, Sasse M. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr. 2013 Feb 6;13:21. doi: 10.1186/1471-2431-13-21. |
| 22527062 | Derived | Jack T, Boehne M, Brent BE, Hoy L, Koditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012 Jun;38(6):1008-16. doi: 10.1007/s00134-012-2539-7. Epub 2012 Apr 12. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |