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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Martin W Duenser, MD, DESA, EDIC, University of Salzburg
ClinicalTrials.gov Identifier:
NCT01534390
First received: February 9, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Salzburg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 504
Study Start Date: April 2012
Estimated Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534390

Locations
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
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

No publications provided

Responsible Party: Martin W Duenser, MD, DESA, EDIC, Dr., University of Salzburg
ClinicalTrials.gov Identifier: NCT01534390     History of Changes
Other Study ID Numbers: 415-E/1442/7-2012
Study First Received: February 9, 2012
Last Updated: April 11, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by University of Salzburg:
microparticles
in-line microfilters
systemic inflammation
organ failure
critical illness
adult

Additional relevant MeSH terms:
Critical Illness
Inflammation
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014