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

The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammation
• Intervention / Treatment: Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days in the intensive care unit with the systemic inflammatory response syndrome	participants will be followed for the duration of ICU stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of the systemic inflammatory response syndrome during the intensive care unit stay	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	participants will be followed for the duration of ICU stay, an expected average of 5 days
Length of stay in the intensive care unit	participants will be followed for the duration of ICU stay, an expected average of 5 days
Duration of mechanical ventilation	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	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	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	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	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	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	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	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	participants will be followed for the duration of ICU stay, an expected average of 5 days

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dunser 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: adult; critical illness; systemic inflammation; microparticles; organ failure; in-line microfilters
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 415-E/1442/7-2012