SepsisNCT02936232
Severe Sepsis and Septic Shock Registry
An observational study of Sepsis, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 3,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Aug 2014to Mar 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis or septic shock
Who may be able to join
- two of more systemic inflammatory reaction syndrome criteria fever > 38.3 'C or hypothermia < 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL)
- suspected or proven infection
- any organ dysfunction as follows:
- cardiovascular (hypotension, systolic blood pressure <90 mmHg, mean arterial pressure <70mmHg)
- tissue hypoperfusion (lactate above upper limits laboratory normal)
- acute lung injury (PaO2/inspired oxygen fraction < 250 in the absence of pneumonia, PaO2/inspired oxygen fraction < 200 in the presence of pneumonia)
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- acute kidney injury (Urine output < 0.5mL/kg/hr for at least 2 hrs Serum creatinine > 2.0 mg/dL)
- acute liver injury (Total bilirubin > 2mg/dL)
- acute coagulopathy (Platelet count < 100,000/μL or prothrombin time, international normalized ratio > 1.5)
Who cannot join
- age less than 18 years old
- patients with cardiac arrest at presentation
- patients with advanced directives not to deliver aggressive organ supportive management
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
You Hwan Jo, MD, PhD, (82)-31-787-7574, drakejo@snubh.org
- Recruiting
Seoul National University Hospital
Seoul, 110714
Kyung Su Kim, MD, PhD, 82-10-8033-1127, kanesu@gmail.com
- Recruiting
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 156-707
Huijai Lee, MD, 82-2-870-2664, emdrlee@gmail.com
About this study
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.
Read the detailed description
This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments.
Registered data can be used for quality control and clinical research to reduce sepsis-related mortality.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
According to hospital discharge record review and telephone follow-up.
Measured: 28-day
Secondary outcomes (5)
90-day mortality
According to hospital discharge record review and telephone follow-up.
Measured: 90-day
Organ support treatment (mechanical ventilation)
According to hospital record review
Measured: hospital discharge (non-survivors) or 90 days (survivors)
Organ support treatment (renal replacement therapy)
According to hospital record review
Measured: hospital discharge (non-survivors) or 90 days (survivors)
ICU length of stay
According to hospital record review
Measured: hospital discharge (non-survivors) or 90 days (survivors)
Hospital length of stay
According to hospital record review
Measured: hospital discharge (non-survivors) or 90 days (survivors)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2014
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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 Seoul National 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
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Hallym University Kangnam Sacred Heart Hospital, Gangnam Severance Hospital, Kyungpook National University Hospital, Kyunghee University Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, The Catholic University of Korea, Samsung Medical Center, Asan Medical Center, Severance Hospital, Ulsan University Hospital, Inje University Ilsan Paik Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Jeju National University Hospital, Chosun University Hospital, Hallym University Medical Center, Hanyang University Seoul Hospital, Bucheon St. Mary's Hospital
- Responsible party
- Principal investigator, Gil Joon Suh, Seoul National University Hospital
- Investigators
- Gil Joon Suh, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936232
- Sponsor's protocol ID
- 1408-003-599
- Status last verified
- Nov 2023
- First submitted
- 9 Oct 2016
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Sepsis and Septic Shock Registry
- ClinicalTrials.gov ID
- NCT02936232
- Acronym / sponsor ID
- 1408-003-599
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Hallym University Kangnam Sacred Heart Hospital, Gangnam Severance Hospital, Kyungpook National University Hospital, Kyunghee University Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, The Catholic University of Korea, Samsung Medical Center, Asan Medical Center, Severance Hospital, Ulsan University Hospital, Inje University Ilsan Paik Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Jeju National University Hospital, Chosun University Hospital, Hallym University Medical Center, Hanyang University Seoul Hospital, Bucheon St. Mary's Hospital
- Study start
- Aug 2014
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Oct 2016 (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.
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.
Detailed description
This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments.
Registered data can be used for quality control and clinical research to reduce sepsis-related mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis or septic shock
Key inclusion criteria (9 listed)
- two of more systemic inflammatory reaction syndrome criteria fever > 38.3 'C or hypothermia < 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL)
- suspected or proven infection
- any organ dysfunction as follows:
Key exclusion criteria (3 listed)
- age less than 18 years old
- patients with cardiac arrest at presentation
- patients with advanced directives not to deliver aggressive organ supportive management
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
28-day mortality
Time frame: 28-day
According to hospital discharge record review and telephone follow-up.
5 secondary outcomes
90-day mortality
Time frame: 90-day
Organ support treatment (mechanical ventilation)
Time frame: hospital discharge (non-survivors) or 90 days (survivors)
Organ support treatment (renal replacement therapy)
Time frame: hospital discharge (non-survivors) or 90 days (survivors)
ICU length of stay
Time frame: hospital discharge (non-survivors) or 90 days (survivors)
Hospital length of stay
Time frame: hospital discharge (non-survivors) or 90 days (survivors)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
Gil Joon Suh, MD, PhD study director
Seoul National University Hospital
3 sites 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 Seoul National University Hospital at 3 sites in South Korea.
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 9 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: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung Su Kim, MD, PhD (82-10-8033-1127, kanesu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28-day). 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 24 Nov 2023.