Systemic Inflammation
Conditions
Keywords
microparticles, in-line microfilters, systemic inflammation, organ failure, critical illness, adult
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.
Interventions
DEVICEIn-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
Sponsors
University of Salzburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Austria
Outcome results
None listed