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

Phase 2

Completed

• Conditions: Systemic Inflammation
• Interventions: Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)

• Registration Number: NCT01534390
• Lead Sponsor: University of Salzburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Study Start: 2012-04
• Primary Completion: 2013-04
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-31
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of in-line microfilters	In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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 candida infections 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
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 venous thrombosis during the intensive care unit stay	participants will be followed for the duration of ICU stay, an expected average of 5 days

Trial Locations

Locations (1)

Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University; 🇦🇹 Salzburg, Austria