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Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients
This study has been completed.
Sponsor:
University of Salzburg
Information provided by (Responsible Party):
Martin W Duenser, MD, DESA, EDIC, University of Salzburg
ClinicalTrials.gov Identifier:
NCT01534390
First received: February 9, 2012
Last updated: May 31, 2015
Last verified: May 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Systemic Inflammation | Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial |
Further study details as provided by Martin W Duenser, MD, DESA, EDIC, University of Salzburg:
Primary Outcome 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 Outcome 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 ]
| Enrollment: | 504 |
| Study Start Date: | April 2012 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Use of in-line microfilters |
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
|
| No Intervention: Standard therapy without the use of in-line microfilters |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01534390
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534390
Locations
| Austria | |
| Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University | |
| Salzburg, Austria, 5020 | |
Sponsors and Collaborators
University of Salzburg
Investigators
| Study Chair: | Martin W Duenser, MD, DESA, EDIC | Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Martin W Duenser, MD, DESA, EDIC, Dr., University of Salzburg |
| ClinicalTrials.gov Identifier: | NCT01534390 History of Changes |
| Other Study ID Numbers: |
415-E/1442/7-2012 |
| Study First Received: | February 9, 2012 |
| Last Updated: | May 31, 2015 |
Keywords provided by Martin W Duenser, MD, DESA, EDIC, University of Salzburg:
|
microparticles in-line microfilters systemic inflammation |
organ failure critical illness adult |
Additional relevant MeSH terms:
|
Inflammation Critical Illness Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on June 23, 2017