SepsisNCT02871024
Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
A study testing Toraymyxin in people with Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Toraymyxin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2016to 26 Mar 2019
- 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 with septic shock defined by the third international consensus definitions for sepsis and septic shock
- Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:
- 2-1. Pneumonia is defined by a new infiltrate on chest radiograph and the presence of one or several of the following signs or symptoms: cough, sputum production, dyspnea, core body temperature ≥ 38.0°C, auscultatory findings of abnormal breath sounds and rales and leukocyte count > 10000 or < 4000/L.
- 2-2. UTI is defined by at least one clinical symptom (core body temperature ≥38.0°C, urinary urgency, polyuria, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting) and one urinary criterion (pyuria >20 leukocytes/μL).
- Hyperlactatemia (>2 mmol/L)
- Endotoxin activity assay (EAA) ≥ 0.5 units.
Who cannot join
- Shock persisted >12 hours before screening
- Mechanical ventilation >21 days
- Uncontrolled hemorrhage
- Thrombocytopenia (platelet count < 30,000 cells/mm3)
- Leukopenia (leukocyte count < 1500 cells/mm3)
- Suspected allergy to polymyxin
- Females with pregnancy
- Terminal cancer or organ failure with life expectancy less than 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage.
- Conditions
- Sepsis
- Being tested
- Toraymyxin
- Keywords
- Polymyxin B, Pneumonia, Sepsis, Urinary tract infection
- Medical subject headings
- Sepsis, Pneumonia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToraymyxinDevice
Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Usual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart Receives: Device: Toraymyxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of sepsis-associated circulatory failure
Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.
Measured: Day 7
Secondary outcomes (8)
Lactate clearance of survived subjects
Comparison of lactate clearance between the intervention group and historical control group. Lactate clearance = (initial lactate level - subsequent lactate level) / (initial lactate level)
Measured: Day 3
Change of endotoxin levels (Endotoxin Activity Assay)
Change of endotoxin levels after the intervention
Measured: Day 3
Change of Sequential Organ Failure Assessment (SOFA) score
Comparison of SOFA score between the intervention group and historical control group.
Measured: Day 7
Vasopressor-free days
Comparison of vasopressor-free days in 7 days between the intervention group and historical control group.
Measured: 7 days
28-day all-cause mortality
Comparison of 28-day all-cause mortality between the intervention group and historical control group.
Measured: 28 days
Catheter-related complications
Comparison of the proportion of the cases with catheter-related complications between the intervention group and historical control group.
Measured: 3 days
Thrombocytopenia (<25,000/μL)
Comparison of the proportion of the cases with thrombocytopenia (<25,000/μL) between the intervention group and historical control group.
Measured: 3 days
Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day
Comparison of the proportion of the cases with major bleeding between the intervention group and historical control group.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ms. Ying Ting Chao, National Taiwan University Hospital
- Investigators
- Sheng-Yuan Ruan, MD, Principal investigator, Natioanl Taiwan University Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871024
- Sponsor's protocol ID
- 201411023RIPB
- Status last verified
- Mar 2019
- First submitted
- 4 Aug 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT02871024
- Acronym / sponsor ID
- 201411023RIPB
- Conditions
- Sepsis
- Keywords
- Polymyxin B, Pneumonia, Sepsis, Urinary tract infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 18 Aug 2016 (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.
Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: ToraymyxinUsual care with two sessions of 2-hour hemoperfusion with Toraymyxin in 24 hours apart |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
- Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:
- 2-1. Pneumonia is defined by a new infiltrate on chest radiograph and the presence of one or several of the following signs or symptoms: cough, sputum production, dyspnea, core body temperature ≥ 38.0°C, auscultatory findings of abnormal breath sounds and rales and leukocyte count > 10000 or < 4000/L.
- 2-2. UTI is defined by at least one clinical symptom (core body temperature ≥38.0°C, urinary urgency, polyuria, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting) and one urinary criterion (pyuria >20 leukocytes/μL).
- Hyperlactatemia (>2 mmol/L)
Key exclusion criteria (8 listed)
- Shock persisted >12 hours before screening
- Mechanical ventilation >21 days
- Uncontrolled hemorrhage
- Thrombocytopenia (platelet count < 30,000 cells/mm3)
- Leukopenia (leukocyte count < 1500 cells/mm3)
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 |
|---|---|---|
| ToraymyxinToraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis | Device | Intervention arm |
Primary outcome
Reversal of sepsis-associated circulatory failure
Time frame: Day 7
Comparison of the proportion of subjects free from vasopressor on Day 7 between the intervention group and historical control group.
8 secondary outcomes
Lactate clearance of survived subjects
Time frame: Day 3
Change of endotoxin levels (Endotoxin Activity Assay)
Time frame: Day 3
Change of Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 7
Vasopressor-free days
Time frame: 7 days
28-day all-cause mortality
Time frame: 28 days
Catheter-related complications
Time frame: 3 days
Thrombocytopenia (<25,000/μL)
Time frame: 3 days
Cases with major bleeding needed transfusion with packed red blood cells > 2 units/day
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Sheng-Yuan Ruan, MD principal investigator
Natioanl Taiwan University Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toraymyxin in people with Sepsis, 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 8 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: stopped early, as of the sponsor's last update on 28 Mar 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 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 was stopped early (reason given: Difficult recruitment). Results are not available in the source record.
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?
Reversal of sepsis-associated circulatory failure (time frame: Day 7). 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 28 Mar 2019.