SepsisNCT03540797
Myeloid-derived Suppressor Cells in Sepsis
An observational study of Sepsis, run by Chung Fu-Tsai at 1 site in Taiwan.
Trial summary
This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sepsis
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2015to 31 Dec 2023
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will include patients admitted with diagnosis of sepsis in this study. Sepsis is defined by the consensus committee of American College of Chest Physicians and Society of Critical Care Medicine. The investigators will interview each patient and their family members, and review the medical records to obtain the baseline information including demographic data, clinical diagnosis, and evidence of dementia or psychiatric disorders. Acute physical and chronic health evaluation (APACHE II) score will be rated by chart review of data obtained within 24 hours of admission. The underlying medical history will also be collected.
Who may be able to join
- Patients must have known origin of infection .
- Systemic inflammatory response syndrome.
Who cannot join
- age less than 18 years
- pregnancy
- known anaphylactoid reaction to colloid fluids
- a life expectancy less than 24 hours,
- inability to provide informed, written consent
- Patients receiving nephrotoxic drugs,
- admitted to the hospital following a surgical procedure,
- sepsis more than 72 hours when screening .
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Gung Memorial Hospital
Linkou District, 333
Fu-Tsai Chung, MD, +886-3-3281200 ext. 8468, vikingchung@yahoo.com.tw
Fu-Tsai Chung, MD
About this study
Official title: The Roles of MDSCs (Myeloid-derived Suppressor Cells) in Adult Patients With Sepsis.
This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| Intensive care unit (ICU) patients with sepsis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of Intensive care unit (ICU) stay
Measured: 28 days
Secondary outcomes (1)
In hospital survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jul 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Fu-Tsai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chung Fu-Tsai, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540797
- Sponsor's protocol ID
- IRB103-6424B
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of MDSCs (Myeloid-derived Suppressor Cells) in Adult Patients With Sepsis.
- ClinicalTrials.gov ID
- NCT03540797
- Acronym / sponsor ID
- IRB103-6424B
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Chung Fu-TsaiUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 May 2018 (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.
This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit (ICU) patients with sepsis | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will include patients admitted with diagnosis of sepsis in this study. Sepsis is defined by the consensus committee of American College of Chest Physicians and Society of Critical Care Medicine. The investigators will interview each patient and their family members, and review the medical records to obtain the baseline information including demographic data, clinical diagnosis, and evidence of dementia or psychiatric disorders. Acute physical and chronic health evaluation (APACHE II) score will be rated by chart review of data obtained within 24 hours of admission. The underlying medical history will also be collected.
Key inclusion criteria (2 listed)
- Patients must have known origin of infection .
- Systemic inflammatory response syndrome.
Key exclusion criteria (8 listed)
- age less than 18 years
- pregnancy
- known anaphylactoid reaction to colloid fluids
- a life expectancy less than 24 hours,
- inability to provide informed, written consent
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
Survival of Intensive care unit (ICU) stay
Time frame: 28 days
1 secondary outcome
In hospital survival
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: No
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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 Sepsis, run by Chung Fu-Tsai 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 2 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: status not confirmed, as of the sponsor's last update on 31 May 2018. 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 Fu-Tsai Chung, MD (+886-3281200 ext. 8468, vikingchung@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of Intensive care unit (ICU) stay (time frame: 28 days). 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 31 May 2018.