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Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01534390
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Martin W Duenser, MD, DESA, EDIC, University of Salzburg

Study Description
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Brief Summary:
Studies showed that infusion or injection of drugs and fluids results in introduction of microparticles into the bloodstream. These microparticles may cause organ damage and stimulate the immune system thus aggravating the underlying disease. Given that critically ill patients are characteristically suffering from a high disease severity and receive large amounts of fluids and drugs, they may be at particular risk of harm by these microparticles. In-line microfilters have been shown to clear microparticles from intravenous drugs and solutions. The investigators hypothesize that use of in-line microfilters reduce the days with the systemic inflammatory response syndrome in adult critically ill patients.

Condition or disease Intervention/treatment Phase
Systemic Inflammation Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Use of in-line microfilters Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)
use of in-line microfilters with a pore size of 0,2 mcm and 1,2 mcm (only if parenteral nutrition is administered) at all intravenous accesses
No Intervention: Standard therapy without the use of in-line microfilters


Outcome Measures
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Primary Outcome Measures :
  1. Number of days in the intensive care unit with the systemic inflammatory response syndrome [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]

Secondary Outcome Measures :
  1. Incidence of the systemic inflammatory response syndrome during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  2. Average number of days with the systemic inflammatory response syndrome during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  3. Length of stay in the intensive care unit [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  4. Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  5. Incidence of acute lung injury and the acute respiratory distress syndrome [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  6. Maximum C-reactive protein serum concentrations during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  7. Maximum leukocyte count during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  8. Incidence of nosocomial infections during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  9. Incidence of nosocomial candida infections during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  10. Incidence of venous thrombosis during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  11. Cumulative insulin requirements during the intensive care unit stay [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
  12. Number of days with hypo- or hyperglycemic blood sugar levels [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • critical illness
  • expected length of stay in the intensive care unit > 24 hours
  • central venous catheter in place or placed within the first 24 hours

Exclusion Criteria:

  • age < 18 years
  • pregnancy
  • neutropenia or known immunesuppresion
  • limited intensive care
  • inclusion into another clinical trial
  • refusal of written informed consent
Contacts and Locations
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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): NCT01534390


Locations
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Austria
Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
Salzburg, Austria, 5020
Sponsors and Collaborators
University of Salzburg
Investigators
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Study Chair: Martin W Duenser, MD, DESA, EDIC Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Martin W Duenser, MD, DESA, EDIC, Dr., University of Salzburg
ClinicalTrials.gov Identifier: NCT01534390    
Other Study ID Numbers: 415-E/1442/7-2012
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
Keywords provided by Martin W Duenser, MD, DESA, EDIC, University of Salzburg:
microparticles
in-line microfilters
systemic inflammation
 organ failure
critical illness
adult
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes