Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients
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ClinicalTrials.gov Identifier: NCT01534390 |
Recruitment Status :
Completed
First Posted : February 16, 2012
Last Update Posted : June 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Inflammation | Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 504 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534390
Austria | |
Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University | |
Salzburg, Austria, 5020 |
Study Chair: | Martin W Duenser, MD, DESA, EDIC | Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University |
Responsible Party: | Martin W Duenser, MD, DESA, EDIC, Dr., University of Salzburg |
ClinicalTrials.gov Identifier: | NCT01534390 |
Other Study ID Numbers: |
415-E/1442/7-2012 |
First Posted: | February 16, 2012 Key Record Dates |
Last Update Posted: | June 2, 2015 |
Last Verified: | May 2015 |
microparticles in-line microfilters systemic inflammation |
organ failure critical illness adult |
Inflammation Pathologic Processes |