Severe Septic ShockNCT04957316
Blood Purification in Patients With Septic Shock
A study testing Triple-effect blood purification filter in people with Severe 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 storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Septic Shock
- What is being tested?
- Triple-effect blood purification filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2021to Jun 2025
- 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
- Critically ill patients with severe septic shock
- Intraabdominal infection, proved or highly suspected gram-negative bacteria infection
- Change of sequential organ failure assessment (SOFA) score is above or equal to 2
- Require norepinephrine infusion to maintain mean arterial pressure above 65 mm Hg
- Lactate level above 4 mmol/L
- SOFA score >= 9 or norepinephrine dose > 0.1 mcg/kg/min
Who cannot join
- Aged < 20
- SOFA score >=16
- Lactate level >=16
- High dose norepinephrine infusion (> 0.3 mcg/kg/min) more than 24 h after SOFA score was >=9
- High dose norepinephrine infusion (> 0.3 mcg/kg/min) more than 24 h after Lactate level was >=4
- White blood cell counts < 1000 cells/μL
Show all 13Show fewer
- Platelet counts < 30 K/μL
- Allergy to heparin
- Receive continuous renal replacement therapy >8 hour before enrollment
- Receive other endotoxin removal filter
- Receive cardiopulmonary resuscitation within 4 weeks before enrollment
- Admitted to ICU for severe septic shock within 4 weeks before enrollment
- APACHE II score > 35 at enrollment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yu-Chang Yeh, MD, PhD, tonyyeh@ntuh.gov.tw
About this study
Official title: Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients With Severe Septic Shock
In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.
Read the detailed description
In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter (oXiris) has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.
This multi-center, prospective, randomized controlled trial will enroll patient with septic shock. After the screening of eligibility and obtaining the signed informed consent, the enrolling patients will be randomly assigned to the following two groups: the control group and the blood purification group. In the control group, patients will receive the treatments for septic shock according to the Surviving Sepsis Campaign guidelines. If the primary care intensivist decides that continuous renal replacement therapy (CRRT) is indicated, the patient will receive CRRT with regular continuous veno-venous hemofiltration filter. In the blood purification group, patients will receive the treatments for septic shock according to the Surviving Sepsis Campaign guidelines. In addition, these patients will receive blood purification treatment with oXiris filter within two hours after enrollment. The blood purification treatment will be continued for up to 72 hours as needed, and a new oXiris filter will be replaced every 12 to 24 hours. If the primary care intensivist decides that continuous renal replacement therapy (CRRT) is indicated at 72h after blood purification, the patient will receive CRRT with regular continuous veno-venous hemofiltration filter.
The following information will be recorded: diagnosis of intensive care unit admission, past medical history, severity of illness, vital signs, blood pressure, infusion doses of vasopressors and inotropes, fluid balance, sequential organ failure assessment score, daily urine output, lactate, creatinine, and other regular laboratory data. Blood sample will be obtained for analysis of the levels of procalcitonin, cytokines (IL-6, IL-10, HMGB-1 and TNF-α), vascular endothelial cell injury biomarker, kidney injury biomarker and intestinal injury biomarkers.
The primary outcome is the difference of the duration of vasopressor between the two groups. The secondary is the proportion of reduction in vasoactive-inotropic score at 72h between the two groups. Other exploratory variables include the the proportion of reduction in vasoactive-inotropic score at other time points, the serum level of cytokines and organ injury biomarkers, and clinical outcomes between the two groups.
- Conditions
- Severe Septic Shock
- Being tested
- Triple-effect blood purification filter
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-effect blood purification filterDevice
Blood purification using the oXiris filter to remove endotoxin, cytokines, and uremic toxins.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Conventional treatment of severe septic shock. |
| Blood purification group | Experimental | Conventional treatment of severe septic shock and blood purification. Receives: Device: Triple-effect blood purification filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of vasopressors and inotropes infusion
Compare the duration of required infusion of vasopressors and inotropes between the two groups
Measured: up to 10 days
Secondary outcomes (1)
Proportion of reduction in vasoactive-inotropic score
Compare the proportion of reduction in vasoactive-inotropic score (VIS) from enrollment to 72 hours after enrollment between the two groups. VIS = dopamine dose * 1 + dobutamine dose *1 + norepinephrine dose *100 + epinephrine dose * 100 + milrinone dose *10 + vasopressin dose x 10000. All above medication doses are calculated with the unit of mcg/kg/min.
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 posted12 Jul 2021
- Study start16 Sep 2021
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Septic ShockStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957316
- Sponsor's protocol ID
- 202007010RIPD
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients With Severe Septic Shock
- ClinicalTrials.gov ID
- NCT04957316
- Acronym / sponsor ID
- 202007010RIPD
- Conditions
- Severe Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Jul 2021 (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 storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.
Detailed description
In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter (oXiris) has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.
This multi-center, prospective, randomized controlled trial will enroll patient with septic shock. After the screening of eligibility and obtaining the signed informed consent, the enrolling patients will be randomly assigned to the following two groups: the control group and the blood purification group. In the control group, patients will receive the treatments for septic shock according to the Surviving Sepsis Campaign guidelines. If the primary care intensivist decides that continuous renal replacement therapy (CRRT) is indicated, the patient will receive CRRT with regular continuous veno-venous hemofiltration filter. In the blood purification group, patients will receive the treatments for septic shock according to the Surviving Sepsis Campaign guidelines. In addition, these patients will receive blood purification treatment with oXiris filter within two hours after enrollment. The blood purification treatment will be continued for up to 72 hours as needed, and a new oXiris filter will be replaced every 12 to 24 hours. If the primary care intensivist decides that continuous renal replacement therapy (CRRT) is indicated at 72h after blood purification, the patient will receive CRRT with regular continuous veno-venous hemofiltration filter.
The following information will be recorded: diagnosis of intensive care unit admission, past medical history, severity of illness, vital signs, blood pressure, infusion doses of vasopressors and inotropes, fluid balance, sequential organ failure assessment score, daily urine output, lactate, creatinine, and other regular laboratory data. Blood sample will be obtained for analysis of the levels of procalcitonin, cytokines (IL-6, IL-10, HMGB-1 and TNF-α), vascular endothelial cell injury biomarker, kidney injury biomarker and intestinal injury biomarkers.
The primary outcome is the difference of the duration of vasopressor between the two groups. The secondary is the proportion of reduction in vasoactive-inotropic score at 72h between the two groups. Other exploratory variables include the the proportion of reduction in vasoactive-inotropic score at other time points, the serum level of cytokines and organ injury biomarkers, and clinical outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Conventional treatment of severe septic shock. |
| Blood purification group | Experimental | Device: Triple-effect blood purification filterConventional treatment of severe septic shock and blood purification. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Critically ill patients with severe septic shock
- Intraabdominal infection, proved or highly suspected gram-negative bacteria infection
- Change of sequential organ failure assessment (SOFA) score is above or equal to 2
- Require norepinephrine infusion to maintain mean arterial pressure above 65 mm Hg
- Lactate level above 4 mmol/L
Key exclusion criteria (13 listed)
- Aged < 20
- SOFA score >=16
- Lactate level >=16
- High dose norepinephrine infusion (> 0.3 mcg/kg/min) more than 24 h after SOFA score was >=9
- High dose norepinephrine infusion (> 0.3 mcg/kg/min) more than 24 h after Lactate level was >=4
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 |
|---|---|---|
| Triple-effect blood purification filterBlood purification using the oXiris filter to remove endotoxin, cytokines, and uremic toxins. | Device | Blood purification group |
Primary outcome
Duration of vasopressors and inotropes infusion
Time frame: up to 10 days
Compare the duration of required infusion of vasopressors and inotropes between the two groups
1 secondary outcome
Proportion of reduction in vasoactive-inotropic score
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple-effect blood purification filter in people with Severe 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chang Yeh, MD, PhD (+886-9-68661829, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of vasopressors and inotropes infusion (time frame: up to 10 days). 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 13 Jul 2022.