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Completed

NCT Number: NCT01534390

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

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.

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Key information

Conditions

Systemic Inflammation Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Salzburg, State of Salzburg, 5020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Duration of mechanical ventilation

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 5 days

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University of Salzburg

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Feb 16, 2012
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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