Severe SepsisNCT02413541
The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
A study testing Polymyxin-B Hemoperfusion and Standard treatment in people with Severe Sepsis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Polymyxin-B Hemoperfusion and Standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to 30 Aug 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SIRS Criteria > or = 2 meets definition
- Source of infection > or = 1 meet definition
- Evidence of organ dysfunction > or = 1 meet definition
Who cannot join
- WBC < 5,000 /ul
- Platelet < 30,000 / ul
- Pregnancy woman
- Advance stage cancer patients (terminally ill) who is refuse to be resuscitated
- Received blood transfusion > 5 units in 24 hrs
- Allergy to Polymyxin-B
Show all 10Show fewer
- High risk and uncontrolled bleeding
- Organ transplant patients
- On immunosuppressive agents within 2 weeks before study
- HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.
- Conditions
- Severe Sepsis
- Being tested
- Polymyxin-B Hemoperfusion, Standard treatment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin-B HemoperfusionProcedure or surgery
Endotoxin removal
Standard treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| High EAA and use Polymyxin-B Hemoperfusion | Experimental | EAA level > 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion Receives: Procedure: Polymyxin-B Hemoperfusion |
| High EAA and not use Polymyxin-B Hemoperfusion | Experimental | EAA level > 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion Receives: Procedure: Standard treatment |
| Low EAA | Active comparator | EAA level < 0.6 and not use Polymyxin-B Hemoperfusion Receives: Procedure: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functions of cell surface markers
CD11b expression on PMN and HLA-DR expression on monocyte
Measured: 3 days
Chemotaxis
Neutrophil function
Measured: 3 days
EAA level
Endotoxin level
Measured: 3 days
Secondary outcomes (5)
Survival rate
Measured: 28 days
Sequential Organ Failure Assessment (SOFA Score)
Measured: 28 days
Acute Kidney Injury and Renal Replacement Therapy incidences
Measured: 28 days
ICU length of stay
Measured: 28 days
Mechanical ventilation free day
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completion30 Aug 2017
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 Severe SepsisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413541
- Sponsor's protocol ID
- IRB.575/56
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2015
- Last updated
- 5 Mar 2021
- Results posted
- No
Publications
Singhan W, Vadcharavivad S, Areepium N, Wittayalertpanya S, Chaijamorn W, Srisawat N. The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support. J Crit Care. 2019 Jun;51:71-76. doi: 10.1016/j.jcrc.2019.02.007. Epub 2019 Feb 5.
PubMed 30769293Srisawat N, Tungsanga S, Lumlertgul N, Komaenthammasophon C, Peerapornratana S, Thamrongsat N, Tiranathanagul K, Praditpornsilpa K, Eiam-Ong S, Tungsanga K, Kellum JA. The effect of polymyxin B hemoperfusion on modulation of human leukocyte antigen DR in severe sepsis patients. Crit Care. 2018 Oct 26;22(1):279. doi: 10.1186/s13054-018-2077-y.
PubMed 30367647
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT02413541
- Acronym / sponsor ID
- IRB.575/56
- Conditions
- Severe Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 10 Apr 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.
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High EAA and use Polymyxin-B Hemoperfusion | Experimental | Procedure: Polymyxin-B HemoperfusionEAA level > 0.6 or EAA = 0.6 and use Polymyxin-B Hemoperfusion |
| High EAA and not use Polymyxin-B Hemoperfusion | Experimental | Procedure: Standard treatmentEAA level > 0.6 or EAA = 0.6 and not use Polymyxin-B Hemoperfusion |
| Low EAA | Active comparator | Procedure: Standard treatmentEAA level < 0.6 and not use Polymyxin-B Hemoperfusion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SIRS Criteria > or = 2 meets definition
- Source of infection > or = 1 meet definition
- Evidence of organ dysfunction > or = 1 meet definition
Key exclusion criteria (10 listed)
- WBC < 5,000 /ul
- Platelet < 30,000 / ul
- Pregnancy woman
- Advance stage cancer patients (terminally ill) who is refuse to be resuscitated
- Received blood transfusion > 5 units in 24 hrs
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 |
|---|---|---|
| Polymyxin-B HemoperfusionEndotoxin removal | Procedure or surgery | High EAA and use Polymyxin-B Hemoperfusion |
| Standard treatment | Procedure or surgery | High EAA and not use Polymyxin-B Hemoperfusion, Low EAA |
Primary outcome
Functions of cell surface markers
Time frame: 3 days
CD11b expression on PMN and HLA-DR expression on monocyte
Chemotaxis
Time frame: 3 days
Neutrophil function
EAA level
Time frame: 3 days
Endotoxin level
5 secondary outcomes
Survival rate
Time frame: 28 days
Sequential Organ Failure Assessment (SOFA Score)
Time frame: 28 days
Acute Kidney Injury and Renal Replacement Therapy incidences
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Mechanical ventilation free day
Time frame: 28 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 5 Mar 2021.
- Derived from this study: PubMed 30769293Singhan W, Vadcharavivad S, Areepium N, Wittayalertpanya S, Chaijamorn W, Srisawat N. The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support. J Crit Care. 2019 Jun;51:71-76. doi: 10.1016/j.jcrc.2019.02.007. Epub 2019 Feb 5.
- Derived from this study: PubMed 30367647Srisawat N, Tungsanga S, Lumlertgul N, Komaenthammasophon C, Peerapornratana S, Thamrongsat N, Tiranathanagul K, Praditpornsilpa K, Eiam-Ong S, Tungsanga K, Kellum JA. The effect of polymyxin B hemoperfusion on modulation of human leukocyte antigen DR in severe sepsis patients. Crit Care. 2018 Oct 26;22(1):279. doi: 10.1186/s13054-018-2077-y.
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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 Polymyxin-B Hemoperfusion and Standard treatment in people with Severe Sepsis, run by Chulalongkorn University at 1 site in Thailand.
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 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 5 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 Thailand. 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?
Functions of cell surface markers (time frame: 3 days). The study lists 3 primary outcomes in all. 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 NCT02413541, 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 5 Mar 2021.