Severe SepsisNCT01957254
Investigate the Activity of Endotoxin in Severe Sepsis
An observational study of Severe Sepsis and Septic Shock, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis and septic shock
Who may be able to join
- ICU patients with new onset of severe sepsis and septic shock
- Presence of at least 2 of the following conditions (These criteria should have occurred between 12 hours before or 6 hours after the onset of the qualifying first organ dysfunction)
- Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
- Tachycardia (heart rate > 90 bpm)
- Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
- Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
Who cannot join
- Patient will be excluded if they
- are under 20 years old or older than 99 years old
- have suffered from severe sepsis or septic shock more than 24 hours
- are pregnant
- were treated with another medicine or device in the trial less than 30 days prior to the admission to this trial
- have received organ transplantation less than 1 years prior to this trial
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- are terminally ill, for examples with metastasis, with a life expectancy of less than 30 days (certified by the attending physician)
- have already received other blood cleaning treatments, such as CVVH, HD, HF, and PE upon entry into the trial
- have chosen palliative care and signed Do Not Resuscitate sheet
- non-native speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigate the Activity of Endotoxin in Patients With Severe Sepsis and Septic Shock
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients. The endotoxin activity will be measured at certain time points according to the protocol.
Read the detailed description
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock.
The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients.
The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin. The critical component of the LAL reagents used in endotoxin tests is derived from blood cells (amebocytes) of the horseshoe crab, Limulus polyphemus. It contains the proteins of the blood clotting mechanism, which is triggered by endotoxins. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter 85) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (Part I, General Tests, No. 6). We will adopt the chromogenic method as purchased from the Associates of Cape Cod Inc. (ACC). The LAL reagent is formulated with a synthetic substrate which gives a yellow color when acted upon by endotoxin activated enzyme. The test is read at 405 nm, usually in a microplate reader. The severity of multiple organ dysfunction and 28-day mortality will be followed up.
- Conditions
- Severe Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Sepsis | Patient with severe sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin activity
The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin.
Measured: baseline
Secondary outcomes (1)
Change of endotoxin activity
Compare the change of endotoxin activity at different time points.
Measured: At enrollment, 24h, 48h, and 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: The quality of Limulus Amebocyte Lysate (LAL) test was poor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, Ph.D., Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957254
- Sponsor's protocol ID
- 201211040RIB
- Status last verified
- Dec 2014
- First submitted
- 4 Jul 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Activity of Endotoxin in Patients With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT01957254
- Acronym / sponsor ID
- 201211040RIB
- Conditions
- Severe Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The quality of Limulus Amebocyte Lysate (LAL) test was poor.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Oct 2013 (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.
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients. The endotoxin activity will be measured at certain time points according to the protocol.
Detailed description
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock.
The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients.
The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin. The critical component of the LAL reagents used in endotoxin tests is derived from blood cells (amebocytes) of the horseshoe crab, Limulus polyphemus. It contains the proteins of the blood clotting mechanism, which is triggered by endotoxins. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter 85) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (Part I, General Tests, No. 6). We will adopt the chromogenic method as purchased from the Associates of Cape Cod Inc. (ACC). The LAL reagent is formulated with a synthetic substrate which gives a yellow color when acted upon by endotoxin activated enzyme. The test is read at 405 nm, usually in a microplate reader. The severity of multiple organ dysfunction and 28-day mortality will be followed up.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Sepsis | – | –Patient with severe sepsis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis and septic shock
Key inclusion criteria (6 listed)
- ICU patients with new onset of severe sepsis and septic shock
- Presence of at least 2 of the following conditions (These criteria should have occurred between 12 hours before or 6 hours after the onset of the qualifying first organ dysfunction)
- Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
- Tachycardia (heart rate > 90 bpm)
- Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
Key exclusion criteria (10 listed)
- Patient will be excluded if they
- are under 20 years old or older than 99 years old
- have suffered from severe sepsis or septic shock more than 24 hours
- are pregnant
- were treated with another medicine or device in the trial less than 30 days prior to the admission to this trial
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
Endotoxin activity
Time frame: baseline
The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin.
1 secondary outcome
Change of endotoxin activity
Time frame: At enrollment, 24h, 48h, and 72h
Results and safety
The study was stopped early (reason given: The quality of Limulus Amebocyte Lysate (LAL) test was poor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Yu-Chang Yeh, Ph.D. principal investigator
Department of Anesthesiology, National Taiwan University Hospital
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 Severe Sepsis 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 6 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: stopped early, as of the sponsor's last update on 3 Dec 2014. 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: The quality of Limulus Amebocyte Lysate (LAL) test was poor.). 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?
Endotoxin activity (time frame: baseline). 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 3 Dec 2014.