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

Systemic Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534390
• Other study ID #: 415-E/1442/7-2012
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2012
• Last updated: May 31, 2015
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Salzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: May 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Inflammation
• Systemic Inflammation

Intervention

Device:
• In-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

Locations

Country	Name	City	State
Austria	Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Salzburg

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Length of stay in the intensive care unit		participants will be followed for the duration of ICU stay, an expected average of 5 days	No
Secondary	Duration of mechanical ventilation		participants will be followed for the duration of ICU stay, an expected average of 5 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes