Septic ShockoXirisNCT02600312
Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
A study testing oXiris in people with Septic Shock and Acute Kidney Injury, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The Oxiris® filter is a registered product for CRRT already safely used in routine care. In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Kidney Injury
- What is being tested?
- oXiris
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Jan 2018
- Phase
- Interventional
- 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
- Patients admitted to intensive care unit (ICU) of age >18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started.
- Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
- Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
Who cannot join
- Infected with Hepatitis B or C or HIV.
- Dependence on dialysis treatment before the actual ICU episode.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Perioperative and Intensive Care (Adult), Skåne University Hospital, Lund
Lund, Skåne County, 22241
About this study
The Oxiris® filter is a registered product for CRRT already safely used in routine care.
In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use.
Read more
But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours.
Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered.
Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.
- Conditions
- Septic Shock, Acute Kidney Injury
- Being tested
- oXiris
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXirisDevice
oXiris CRRT filter which adsorbs cytokines, toxins.
| Study group | Role | What they receive |
|---|---|---|
| oXiris | Active comparator | Continuous renal replacement therapy with filter that adsorbs cytokines/toxins. Receives: Device: oXiris |
| ST150 | No intervention | Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
endotoxin level in blood
Describes the load of toxins from the septic state. Higher load means increased impact from the infectious state mediated through the septic shock.
Expected mean differences in endotoxin levels including standard deviation is based on data from a previous study on extracorporeal endotoxin removal in sepsis patients (reference 1).
Measured: change from baseline to 48 hours
Secondary outcomes (5)
mean blood pressure
Additional parameter that describes the clinical impact from the septic state.
Measured: hourly up to 48 hours
TNF-α level in blood
Additional parameter that describes the load from the septic shock.
Measured: change from baseline to 48 hours
IL-1β level in blood
Additional parameter that describes the load from the septic shock.
Measured: change from baseline to 48 hours
IL-6 level in blood
Additional parameter that describes the load from the septic shock.
Measured: change from baseline to 48 hours
IL-10
Additional parameter that describes the load from the septic shock.
Measured: change from baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Broman, Skane University Hospital
- Investigators
- Marcus Broman, Associate professor, Principal investigator, Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600312
- Sponsor's protocol ID
- oXiris
- Acronym
- oXiris
- Status last verified
- Jul 2019
- First submitted
- 30 Oct 2015
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ala-Kokko TI, Laurila J, Koskenkari J. A new endotoxin adsorber in septic shock: observational case series. Blood Purif. 2011;32(4):303-9. doi: 10.1159/000330323. Epub 2011 Sep 2.
PubMed 21893976Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
PubMed 34519356
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT02600312
- Acronym / sponsor ID
- oXiris / oXiris
- Conditions
- Septic Shock, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Nov 2015 (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.
The Oxiris® filter is a registered product for CRRT already safely used in routine care.
In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use.
But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours.
Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered.
Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oXiris | Active comparator | Device: oXirisContinuous renal replacement therapy with filter that adsorbs cytokines/toxins. |
| ST150 | No intervention | –Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to intensive care unit (ICU) of age >18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started.
- Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
- Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
Key exclusion criteria (2 listed)
- Infected with Hepatitis B or C or HIV.
- Dependence on dialysis treatment before the actual ICU episode.
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 |
|---|---|---|
| oXirisoXiris CRRT filter which adsorbs cytokines, toxins. | Device | oXiris |
Primary outcome
endotoxin level in blood
Time frame: change from baseline to 48 hours
Describes the load of toxins from the septic state. Higher load means increased impact from the infectious state mediated through the septic shock. Expected mean differences in endotoxin levels including standard deviation is based on data from a previous study on extracorporeal endotoxin removal in sepsis patients (reference 1).
5 secondary outcomes
mean blood pressure
Time frame: hourly up to 48 hours
TNF-α level in blood
Time frame: change from baseline to 48 hours
IL-1β level in blood
Time frame: change from baseline to 48 hours
IL-6 level in blood
Time frame: change from baseline to 48 hours
IL-10
Time frame: change from baseline to 48 hours
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 26 Jul 2019.
- Results publication: PubMed 21893976Ala-Kokko TI, Laurila J, Koskenkari J. A new endotoxin adsorber in septic shock: observational case series. Blood Purif. 2011;32(4):303-9. doi: 10.1159/000330323. Epub 2011 Sep 2.
- Derived from this study: PubMed 34519356Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
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Sepsis
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.
Marcus Broman, Associate professor principal investigator
Dep Perioperative and Intensive Care, Skåne University Hospital, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oXiris in people with Septic Shock and Acute Kidney Injury, run by Skane University Hospital at 1 site in Sweden.
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 3 inclusion and 2 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 26 Jul 2019. 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 Sweden. 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.
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?
endotoxin level in blood (time frame: change from baseline to 48 hours). 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 NCT02600312, which also lists 2 linked publications.
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 26 Jul 2019.