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Use of In-Line Filtration in Critically Ill Children

This study has been completed.
Sponsor:
Collaborators:
Pall GmbH Medical
B. Braun Melsungen AG
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00209768
First received: September 13, 2005
Last updated: November 28, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00209768     History of Changes
Other Study ID Numbers: 3702
Study First Received: September 13, 2005
Last Updated: November 28, 2008
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013