Use of In-Line Filtration in Critically Ill Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00209768
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 1, 2008
Pall GmbH Medical
B. Braun Melsungen AG
Information provided by:
Hannover Medical School

September 13, 2005
September 21, 2005
December 1, 2008
February 2005
September 2008   (Final data collection date for primary outcome measure)
  • Sepsis
  • Thrombosis
  • SIRS
  • Organ failure
  • Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
Same as current
Complete list of historical versions of study NCT00209768 on Archive Site
  • Duration of Pediatric Intensive Care Unit stay
  • Duration of overall hospital stay
Same as current
Not Provided
Not Provided
Use of In-Line Filtration in Critically Ill Children
Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children
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:

  • 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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Critical Illness
Device: Filter: NOE96E, ELD96E, NLF1E, TNA1E
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children admitted to pediatric intensive care unit (PICU)

Exclusion Criteria:

  • Suspected death within 48 hours
  • Duration of PICU stay less than 6 hours
  • Patients recruited for Simulect or Sintra Study
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Hannover Medical School
  • Pall GmbH Medical
  • B. Braun Melsungen AG
Study Director: Michael Sasse, Consultant Medical School Hannover
Principal Investigator: Thomas Jack, Doctor Medical School Hannover
Hannover Medical School
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP