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

University of Salzburg

Status and phase: Completed; Phase 2

Conditions: Systemic Inflammation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01534390

415-E/1442/7-2012

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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504 participants in 2 patient groups

Use of in-line microfilters

Experimental group

Treatment:

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

Standard therapy without the use of in-line microfilters

No Intervention group