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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Use of in-line microfilters

Group Type EXPERIMENTAL

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

Intervention Type 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

Standard therapy without the use of in-line microfilters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No