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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01534390

First Posted: February 16, 2012

Last Update Posted: June 2, 2015

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.

Information provided by (Responsible Party):

Martin W Duenser, MD, DESA, EDIC, University of Salzburg

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 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

Further study details as provided by Martin W Duenser, MD, DESA, EDIC, 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 ]

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 ]
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 ]
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 ]
Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]


Enrollment:	504
Study Start Date:	April 2012
Study Completion Date:	May 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


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

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

Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dünser MW, Grander W. Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial. Ann Intensive Care. 2015 Dec;5(1):36. doi: 10.1186/s13613-015-0080-x. Epub 2015 Nov 4.


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
First Submitted:	February 9, 2012
First Posted:	February 16, 2012
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:


Inflammation Critical Illness Pathologic Processes Disease Attributes

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