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

Primary Purpose

Systemic Inflammation

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Systemic Inflammation focused on measuring microparticles, in-line microfilters, systemic inflammation, organ failure, critical illness, adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Use of in-line microfilters

Standard therapy without the use of in-line microfilters

Arm Description

Outcomes

Primary Outcome Measures

Number of days in the intensive care unit with the systemic inflammatory response syndrome

Secondary Outcome Measures

Incidence of the systemic inflammatory response syndrome during the intensive care unit stay

Average number of days with the systemic inflammatory response syndrome during the intensive care unit stay

Length of stay in the intensive care unit

Duration of mechanical ventilation

Incidence of acute lung injury and the acute respiratory distress syndrome

Maximum C-reactive protein serum concentrations during the intensive care unit stay

Maximum leukocyte count during the intensive care unit stay

Incidence of nosocomial infections during the intensive care unit stay

Incidence of nosocomial candida infections during the intensive care unit stay

Incidence of venous thrombosis during the intensive care unit stay

Cumulative insulin requirements during the intensive care unit stay

Number of days with hypo- or hyperglycemic blood sugar levels

Full Information

NCT ID

NCT01534390

First Posted

February 9, 2012

Last Updated

May 31, 2015

Sponsor

University of Salzburg

1. Study Identification

Unique Protocol Identification Number

NCT01534390

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Salzburg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Inflammation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

504 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Use of in-line microfilters

Arm Type

Experimental

Arm Title

Standard therapy without the use of in-line microfilters

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of days in the intensive care unit with the systemic inflammatory response syndrome

Time Frame