Systemic InflammationPhase 2NCT01534390
Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients
A Phase 2 study testing In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) in people with Systemic Inflammation, run by University of Salzburg at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammation
- What is being tested?
- In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2012to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- refusal of written informed consent
Who cannot join
- age < 18 years
- pregnancy
- neutropenia or known immunesuppresion
- limited intensive care
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
Salzburg, State of Salzburg, 5020
About this study
Official title: The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial
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.
- Conditions
- Systemic Inflammation
- Being tested
- In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)
- Keywords
- microparticles, in-line microfilters, systemic inflammation, organ failure, critical illness, adult
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Use of in-line microfilters | Experimental | Not described Receives: Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) |
| Standard therapy without the use of in-line microfilters | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days in the intensive care unit with the systemic inflammatory response syndrome
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Secondary outcomes (12)
Incidence of the systemic inflammatory response syndrome during the intensive care unit stay
Measured: 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
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Length of stay in the intensive care unit
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Duration of mechanical ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: participants will be followed for the duration of ICU stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salzburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin W Duenser, MD, DESA, EDIC, University of Salzburg
- Investigators
- Martin W Duenser, MD, DESA, EDIC, Study chair, Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534390
- Sponsor's protocol ID
- 415-E/1442/7-2012
- Status last verified
- May 2015
- First submitted
- 9 Feb 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dunser MW, Grander W. Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial. Ann Intensive Care. 2015 Dec;5(1):36. doi: 10.1186/s13613-015-0080-x. Epub 2015 Nov 4.
PubMed 26538309
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01534390
- Acronym / sponsor ID
- 415-E/1442/7-2012
- Conditions
- Systemic Inflammation
- Keywords
- microparticles, in-line microfilters, systemic inflammation, organ failure, critical illness, adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of SalzburgUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of in-line microfilters | Experimental | Device: In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) |
| Standard therapy without the use of in-line microfilters | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- refusal of written informed consent
Key exclusion criteria (4 listed)
- age < 18 years
- pregnancy
- neutropenia or known immunesuppresion
- limited intensive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Use of in-line microfilters |
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 26538309Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dunser MW, Grander W. Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial. Ann Intensive Care. 2015 Dec;5(1):36. doi: 10.1186/s13613-015-0080-x. Epub 2015 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin W Duenser, MD, DESA, EDIC study chair
Department of Anesthesiology, perioperative and intensive care medicine, Salzburg General Hospital and Paracelsus Private Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York) in people with Systemic Inflammation, run by University of Salzburg at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.