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

NCT01534390 | Completed Phase 2

• 1 other identifier: 415-E/1442/7-2012
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammation

Keywords

microparticles; in-line microfilters; systemic inflammation; organ failure; critical illness; adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Study Arms (2)

Use of in-line microfilters

EXPERIMENTAL

Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)

Standard therapy without the use of in-line microfilters

NO INTERVENTION

Interventions

In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) DEVICE

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

Use of in-line microfilters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years
• pregnancy
• neutropenia or known immunesuppresion
• limited intensive care
• refusal of written informed consent

Sponsors & Collaborators

• University of Salzburg: lead

Study Sites (1)

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

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (1)

• 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.

  PMID: 26538309 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin W Duenser, MD, DESA, EDIC

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 16, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

AU (1)