SepsisNCT02452138
Endotoxin Activity Assay and Microcirculation in Severe Sepsis
An observational study of Sepsis, run by National Taiwan University Hospital.
Trial summary
Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Severe sepsis management
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis
Who may be able to join
- patients with the following infections: intraabdominal infection, pneumonia, urinary tract infection, blood stream infection, or wound infection
- patients must also meet any one of the following criteria for severe sepsis
- SBP < 90 mm Hg, MAP < 65 mm Hg, or requirement of vasopressors or inotropics
- PaO2/FiO2 < 300
- Creatinine level > 2 mg/dL or increase > 0.5 mg/dL; or urine output < 0.5 mL/kg/h more than 2 hours
- Bilirubin level > 4 mg/dL
Show all 10Show fewer
- Platelet count < 100 k/uL or decrease more than 50%
- INR > 1.5 or aPTT > 60 sec
- GCS < 13 or 9T
- Lactate > 2 mmol/L (with pH < 7.3 or base excess < -5 mmol/L)
Who cannot join
- younger than 20 yeras old or greater than 99 years old
- the onset of severe sepsis before enrollment is greater than 24 hours
- pregnant
- have received plymyxin-B hemoperfusion within 24 hours before enrollment
- non-native speaker
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endotoxin Activity Assay and Microcirculation Examination in Patients With Severe Sepsis
Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction. When microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and death. This is a prospective observational study, and it will not influence the sepsis treatment decision of the medical care team. The critically ill severe sepsis patients will be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and sign the consent form after explanation of the aim and process of the trial by the primary investigator or research personnel. After enrollment, the patient will receive serum assay of endotoxin activity (EAA) and endocan level. The patient will also receive examination of sublingual microcirculation by using the incident dark field video microscope. After 24 hours, the patient will receive assay of endocan level and examination of sublingual microcirculation. This study will record the vital signs, laboratory data, dose of vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this study will check the survival, stay of intensive care, stay of hospital, ventilator day, and the results of culture of pathogens. The patients will be assign to the following three groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59 EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for statistical analysis and comparison. The primary goal of this study is to investigate the difference of the prevalence of gram-negative bacteria infection, pathogen, infection source, microcirculation, the severity of disease, and the prognosis among these three groups.
- Conditions
- Sepsis
- Being tested
- Severe sepsis management
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe sepsis managementOther
| Study group | Role | What they receive |
|---|---|---|
| Low EAA | Endotoxin Activity Assay [EAA] level < 0.40 EAA units Receives: Other: Severe sepsis management | |
| Intermediate EAA | Endotoxin Activity Assay [EAA] level between 0.40-0.59 EAA units Receives: Other: Severe sepsis management | |
| High EAA | Endotoxin Activity Assay [EAA] level >= 0.60 EAA units Receives: Other: Severe sepsis management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the prevalence of gram-negative bacteria infection
Compare the prevalnce of gram-negative bacteria infection among the three groups
Measured: At enrollment
Secondary outcomes (5)
Difference of Total small vessel density
Total small vessel density will be measured by incident dark field video microscope. Compare the difference among the three groups.
Measured: At Enrollment
Difference of Perfused small vessel density
Perfused small vessel density will be measured by incident dark field video microscope. Compare the difference among the three groups.
Measured: At enrollment
Endocan level
Endocan level will be measured by Human Endocan kit. Compare the difference among the three groups.
Measured: At enrollment
SOFA score
Compare the Sequential Organ Failure Assessment score among the three groups
Measured: At enrollement
28-day mortality
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 posted22 May 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452138
- Sponsor's protocol ID
- 201503015RINB
- Status last verified
- Dec 2015
- First submitted
- 20 May 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotoxin Activity Assay and Microcirculation Examination in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT02452138
- Acronym / sponsor ID
- 201503015RINB
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 May 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.
Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction. When microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and death. This is a prospective observational study, and it will not influence the sepsis treatment decision of the medical care team. The critically ill severe sepsis patients will be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and sign the consent form after explanation of the aim and process of the trial by the primary investigator or research personnel. After enrollment, the patient will receive serum assay of endotoxin activity (EAA) and endocan level. The patient will also receive examination of sublingual microcirculation by using the incident dark field video microscope. After 24 hours, the patient will receive assay of endocan level and examination of sublingual microcirculation. This study will record the vital signs, laboratory data, dose of vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this study will check the survival, stay of intensive care, stay of hospital, ventilator day, and the results of culture of pathogens. The patients will be assign to the following three groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59 EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for statistical analysis and comparison. The primary goal of this study is to investigate the difference of the prevalence of gram-negative bacteria infection, pathogen, infection source, microcirculation, the severity of disease, and the prognosis among these three groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low EAA | – | Other: Severe sepsis managementEndotoxin Activity Assay [EAA] level < 0.40 EAA units |
| Intermediate EAA | – | Other: Severe sepsis managementEndotoxin Activity Assay [EAA] level between 0.40-0.59 EAA units |
| High EAA | – | Other: Severe sepsis managementEndotoxin Activity Assay [EAA] level >= 0.60 EAA units |
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
Key inclusion criteria (10 listed)
- patients with the following infections: intraabdominal infection, pneumonia, urinary tract infection, blood stream infection, or wound infection
- patients must also meet any one of the following criteria for severe sepsis
Key exclusion criteria (5 listed)
- younger than 20 yeras old or greater than 99 years old
- the onset of severe sepsis before enrollment is greater than 24 hours
- pregnant
- have received plymyxin-B hemoperfusion within 24 hours before enrollment
- non-native speaker
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 |
|---|---|---|
| Severe sepsis management | Other | High EAA, Intermediate EAA, Low EAA |
Primary outcome
Difference of the prevalence of gram-negative bacteria infection
Time frame: At enrollment
Compare the prevalnce of gram-negative bacteria infection among the three groups
5 secondary outcomes
Difference of Total small vessel density
Time frame: At Enrollment
Difference of Perfused small vessel density
Time frame: At enrollment
Endocan level
Time frame: At enrollment
SOFA score
Time frame: At enrollement
28-day mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by National Taiwan University Hospital.
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 10 inclusion and 5 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 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (886-9-10513711, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the prevalence of gram-negative bacteria infection (time frame: At enrollment). 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 18 Dec 2015.