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

Study Overview
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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.

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

Conditions
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Systemic Inflammation

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of in-line microfilters<br> | Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)<br>* 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<br>|
| No Intervention: Standard therapy without the use of in-line microfilters<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microparticles, in-line microfilters, systemic inflammation, organ failure, critical illness, adult