Sepsis, SevereNCT03974386
Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock
A study testing oXiris blood purification set in people with Sepsis, Severe and Septic Shock, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis, Severe, Septic Shock
- What is being tested?
- oXiris blood purification set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 20 Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all criteria (A+B+C):
- A) Identified infection source under adequate treatment
- B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
- C) Severe septic shock (serum lactate > 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is > 0.2 mcg/kg/min for more than 1 hour or >0.1 mcg/kg/min for more than 3 hours )
Who cannot join
- Onset of severe septic shock more than 24 hours
- Received continuous renal replacement therapy within 24 hours before enrollment
- Serum white blood cell count count < 1000 cells/μL or Platelet count < 50000 cells/μL
- History of allergy to heparin
- Received cardiopulmonary resuscitation within 4 weeks before enrollment
- ICU admission due to severe septic shock within 2 months
Show all 10Show fewer
- Patients or Family had chosen palliative care and signed an agreement to deny aggressive treatment
- Pregnancy
- APACHE II Score > 30 at enrollment
- Non-native speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.
Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.
- Conditions
- Sepsis, Severe, Septic Shock
- Being tested
- oXiris blood purification set
- Keywords
- critical care, septic shock, hemofiltration, endotoxin, cytokine storm, prognosis
- Medical subject headings
- Sepsis, Shock, Septic, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris blood purification setDevice
Continuous venovenous hemofiltration and adsorption (CVVHA) with oXiris filter for up to 72 hours if required. The filter will be replaced every 24 hours. The setting of CVVHA is as follows: blood flow rate 200 mL/min, replacement fluid rate 2000 mL/hr, pre-dilution 50% and post-dilution 50%. If continuous renal replacement therapy is indicated after 72 hours, conventional hemofiltration filters will be used.
| Study group | Role | What they receive |
|---|---|---|
| Blood Purification | Experimental | Patients will receive resuscitation and treatment according to current guidelines for septic shock. In addition to standard care, the patients will receive continuous venovenous hemofiltration and adsorption with oXiris blood purification set. Receives: Device: oXiris blood purification set |
| Conventional Treatment | No intervention | Patients will receive standard care, including resuscitation and treatment according to current guidelines for septic shock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of serum interleukin-6 level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Secondary outcomes (32)
Difference of serum interleukin-6 level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum interleukin-6 level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of serum interleukin-1β level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of serum interleukin-1β level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum interleukin-1β level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of serum interleukin-10 level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of serum interleukin-10 level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum interleukin-10 level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of serum procalcitonin level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of serum procalcitonin level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum procalcitonin level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of mean arterial pressure
Comparison to enrollment
Measured: 24 hours
Difference of mean arterial pressure
Comparison to enrollment
Measured: 48 hours
Difference of mean arterial pressure
Comparison to enrollment
Measured: 72 hours
Difference of cardiac output
Comparison to enrollment
Measured: 24 hours
Difference of cardiac output
Comparison to enrollment
Measured: 48 hours
Difference of cardiac output
Comparison to enrollment
Measured: 72 hours
Difference of norepinephrine infusion rate
Comparison to enrollment
Measured: 24 hours
Difference of norepinephrine infusion rate
Comparison to enrollment
Measured: 48 hours
Difference of norepinephrine infusion rate
Comparison to enrollment
Measured: 72 hours
Difference of the sequential organ failure assessment score
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of the sequential organ failure assessment score
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of the sequential organ failure assessment score
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of serum endocan level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of serum endocan level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum endocan level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of serum diamine oxidase level
Comparison to enrollment or between 2 groups
Measured: 24 hours
Difference of serum diamine oxidase level
Comparison to enrollment or between 2 groups
Measured: 48 hours
Difference of serum diamine oxidase level
Comparison to enrollment or between 2 groups
Measured: 72 hours
Difference of daily IV fluids
Comparison between 2 groups
Measured: 24 hours
Difference of daily IV fluids
Comparison between 2 groups
Measured: 48 hours
Difference of daily IV fluids
Comparison between 2 groups
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jul 2019
- Primary completion17 Jul 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, SevereStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974386
- Sponsor's protocol ID
- 201808098DIPC
- Status last verified
- Mar 2021
- First submitted
- 2 Jun 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
- ClinicalTrials.gov ID
- NCT03974386
- Acronym / sponsor ID
- 201808098DIPC
- Conditions
- Sepsis, Severe, Septic Shock
- Keywords
- critical care, septic shock, hemofiltration, endotoxin, cytokine storm, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- 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.
In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.
Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Purification | Experimental | Device: oXiris blood purification setPatients will receive resuscitation and treatment according to current guidelines for septic shock. In addition to standard care, the patients will receive continuous venovenous hemofiltration and adsorption with oXiris blood purification set. |
| Conventional Treatment | No intervention | –Patients will receive standard care, including resuscitation and treatment according to current guidelines for septic shock. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet all criteria (A+B+C):
- A) Identified infection source under adequate treatment
- B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
- C) Severe septic shock (serum lactate > 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is > 0.2 mcg/kg/min for more than 1 hour or >0.1 mcg/kg/min for more than 3 hours )
Key exclusion criteria (10 listed)
- Onset of severe septic shock more than 24 hours
- Received continuous renal replacement therapy within 24 hours before enrollment
- Serum white blood cell count count < 1000 cells/μL or Platelet count < 50000 cells/μL
- History of allergy to heparin
- Received cardiopulmonary resuscitation within 4 weeks before enrollment
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 |
|---|---|---|
| oXiris blood purification setContinuous venovenous hemofiltration and adsorption (CVVHA) with oXiris filter for up to 72 hours if required. The filter will be replaced every 24 hours. The setting of CVVHA is as follows: blood flow rate 200 mL/min, replacement fluid rate 2000 mL/hr, pre-dilution 50% and post-dilution 50%. If continuous renal replacement therapy is indicated after 72 hours, conventional hemofiltration filters will be used. | Device | Blood Purification |
Primary outcome
Difference of serum interleukin-6 level
Time frame: 24 hours
Comparison to enrollment or between 2 groups
32 secondary outcomes
Difference of serum interleukin-6 level
Time frame: 48 hours
Difference of serum interleukin-6 level
Time frame: 72 hours
Difference of serum interleukin-1β level
Time frame: 24 hours
Difference of serum interleukin-1β level
Time frame: 48 hours
Difference of serum interleukin-1β level
Time frame: 72 hours
Difference of serum interleukin-10 level
Time frame: 24 hours
Difference of serum interleukin-10 level
Time frame: 48 hours
Difference of serum interleukin-10 level
Time frame: 72 hours
Difference of serum procalcitonin level
Time frame: 24 hours
Difference of serum procalcitonin level
Time frame: 48 hours
Difference of serum procalcitonin level
Time frame: 72 hours
Difference of mean arterial pressure
Time frame: 24 hours
Difference of mean arterial pressure
Time frame: 48 hours
Difference of mean arterial pressure
Time frame: 72 hours
Difference of cardiac output
Time frame: 24 hours
Difference of cardiac output
Time frame: 48 hours
Difference of cardiac output
Time frame: 72 hours
Difference of norepinephrine infusion rate
Time frame: 24 hours
Difference of norepinephrine infusion rate
Time frame: 48 hours
Difference of norepinephrine infusion rate
Time frame: 72 hours
Difference of the sequential organ failure assessment score
Time frame: 24 hours
Difference of the sequential organ failure assessment score
Time frame: 48 hours
Difference of the sequential organ failure assessment score
Time frame: 72 hours
Difference of serum endocan level
Time frame: 24 hours
Difference of serum endocan level
Time frame: 48 hours
Difference of serum endocan level
Time frame: 72 hours
Difference of serum diamine oxidase level
Time frame: 24 hours
Difference of serum diamine oxidase level
Time frame: 48 hours
Difference of serum diamine oxidase level
Time frame: 72 hours
Difference of daily IV fluids
Time frame: 24 hours
Difference of daily IV fluids
Time frame: 48 hours
Difference of daily IV fluids
Time frame: 72 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 12 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 blood purification set in people with Sepsis, Severe and Septic Shock, run by National Taiwan University Hospital at 1 site in Taiwan.
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 10 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 12 Mar 2021. 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 Taiwan. 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?
Difference of serum interleukin-6 level (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.