Clinical trial NCT01534390: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Inflammation
Keywords: microparticles
in-line microfilters
systemic inflammation
organ failure
critical illness
adult
Lead sponsor: University of Salzburg
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of days in the intensive care unit with the systemic inflammatory response syndrome
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
Secondary outcomes:
measure: Incidence of the systemic inflammatory response syndrome during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Average number of days with the systemic inflammatory response syndrome during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Length of stay in the intensive care unit
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Duration of mechanical ventilation
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Incidence of acute lung injury and the acute respiratory distress syndrome
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Maximum C-reactive protein serum concentrations during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Maximum leukocyte count during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Incidence of nosocomial infections during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Incidence of nosocomial candida infections during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Incidence of venous thrombosis during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Cumulative insulin requirements during the intensive care unit stay
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: Number of days with hypo- or hyperglycemic blood sugar levels
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
Study officials:
affiliation: Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
name: Martin W Duenser, MD, DESA, EDIC
role: STUDY_CHAIR
References:
citation: Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dunser MW, Grander W. Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial. Ann Intensive Care. 2015 Dec;5(1):36. doi: 10.1186/s13613-015-0080-x. Epub 2015 Nov 4.