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

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 ]


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


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


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:	May 31, 2015
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:


Inflammation Critical Illness Pathologic Processes Disease Attributes

ClinicalTrials.gov processed this record on September 30, 2016