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Use of In-Line Filtration in Critically Ill Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209768
First Posted: September 21, 2005
Last Update Posted: December 1, 2008
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.
Collaborators:
Pall GmbH Medical
B. Braun Melsungen AG
Information provided by:
Hannover Medical School
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Sepsis
  • Thrombosis
  • SIRS
  • Organ failure
  • Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"

Secondary Outcome Measures:
  • Duration of Pediatric Intensive Care Unit stay
  • Duration of overall hospital stay

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)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Hannover Medical School
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Pall GmbH Medical
B. Braun Melsungen AG
Investigators
Study Director: Michael Sasse, Consultant Medical School Hannover
Principal Investigator: Thomas Jack, Doctor Medical School Hannover
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00209768     History of Changes
Other Study ID Numbers: 3702
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 1, 2008
Last Verified: September 2008

Keywords provided by Hannover Medical School:
pediatric intensive care
critically ill children
in-line filtration
prospective randomized study
complications
sepsis
SIRS
thrombosis
organ failure

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes