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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Use of in-line microfilters
  • No Intervention: Standard therapy without the use of in-line microfilters

Clinical Trial Outcome Measures

Primary Measures

  • Number of days in the intensive care unit with the systemic inflammatory response syndrome
    • Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days

Secondary Measures

  • Incidence of the systemic inflammatory response syndrome during the intensive care unit stay
    • Time Frame: 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
    • Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days
  • Length of stay in the intensive care unit
    • Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days
  • Duration of mechanical ventilation
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Salzburg
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin W Duenser, MD, DESA, EDIC, Dr. – University of Salzburg
  • Overall Official(s)
    • Martin W Duenser, MD, DESA, EDIC, Study Chair, Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University

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