Septic ShockNCT03177330
Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion
An observational study of Septic Shock and Polymyxin B Hemoperfusion, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Septic Shock, Polymyxin B Hemoperfusion
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2017to Jul 2017
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion
Who may be able to join
- intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016
Who cannot join
- pregnant woman
- patients with do-not-resuscitate declaration
- uncontrolled bleeding within 24hr
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, NTUH, Taipei, Taiwan
Taipei
Chen-Tse Lee, M.D., +886-2-23123456 ext. 62158, lctbrian314@gmail.com
Chen-Tse Lee, M.D.
About this study
Official title: Safety and Efficacy of Heparin Dosing Score Protocol for Anticoagulation During Polymyxin-B Hemoperfusion: a Retrospective Study
Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.
- Conditions
- Septic Shock, Polymyxin B Hemoperfusion
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
premature cartridge clotting rate
the incidence of premature cartridge clotting within 2hr
Measured: 2 hours
Secondary outcomes (1)
bleeding event rate
the incidence of substantial bleeding event within 24hr
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start15 May 2017
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
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
- NCT03177330
- Sponsor's protocol ID
- 201704033RIND
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Heparin Dosing Score Protocol for Anticoagulation During Polymyxin-B Hemoperfusion: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03177330
- Acronym / sponsor ID
- 201704033RIND
- Conditions
- Septic Shock, Polymyxin B Hemoperfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Jun 2017 (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.
Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion
Key inclusion criteria (1 listed)
- intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016
Key exclusion criteria (3 listed)
- pregnant woman
- patients with do-not-resuscitate declaration
- uncontrolled bleeding within 24hr
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
premature cartridge clotting rate
Time frame: 2 hours
the incidence of premature cartridge clotting within 2hr
1 secondary outcome
bleeding event rate
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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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?
An observational study of Septic Shock and Polymyxin B Hemoperfusion, 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 1 inclusion and 3 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 6 Jun 2017. 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 Chen-Tse Lee, MD (+886972653169, lctbrian314@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
premature cartridge clotting rate (time frame: 2 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 6 Jun 2017.