- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936232
Severe Sepsis and Septic Shock Registry
March 21, 2021 updated by: Gil Joon Suh, Seoul National University Hospital
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kyung Su Kim, MD, PhD
- Phone Number: 82-10-8033-1127
- Email: kanesu@gmail.com
Study Contact Backup
- Name: Woon Wong Kwon, MD, PhD
- Phone Number: 82-2-2072-4751
- Email: kwy711@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 110714
- Recruiting
- Seoul National University Hospital
-
Contact:
- Kyung Su Kim, MD, PhD
- Phone Number: 82-10-8033-1127
- Email: kanesu@gmail.com
-
Seoul, Korea, Republic of, 156-707
- Recruiting
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
-
Contact:
- Huijai Lee, MD
- Phone Number: 82-2-870-2664
- Email: emdrlee@gmail.com
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463707
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- You Hwan Jo, MD, PhD
- Phone Number: (82)-31-787-7574
- Email: drakejo@snubh.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with severe sepsis or septic shock
Description
Inclusion Criteria:
- 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)
- 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)
Exclusion Criteria:
- age less than 18 years old
- patients with cardiac arrest at presentation
- patients with advanced directives not to deliver aggressive organ supportive management
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day mortality
Time Frame: 28-day
|
According to hospital discharge record review and telephone follow-up.
|
28-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
90-day mortality
Time Frame: 90-day
|
According to hospital discharge record review and telephone follow-up.
|
90-day
|
Organ support treatment (mechanical ventilation)
Time Frame: hospital discharge (non-survivors) or 90 days (survivors)
|
According to hospital record review
|
hospital discharge (non-survivors) or 90 days (survivors)
|
Organ support treatment (renal replacement therapy)
Time Frame: hospital discharge (non-survivors) or 90 days (survivors)
|
According to hospital record review
|
hospital discharge (non-survivors) or 90 days (survivors)
|
ICU length of stay
Time Frame: hospital discharge (non-survivors) or 90 days (survivors)
|
According to hospital record review
|
hospital discharge (non-survivors) or 90 days (survivors)
|
Hospital length of stay
Time Frame: hospital discharge (non-survivors) or 90 days (survivors)
|
According to hospital record review
|
hospital discharge (non-survivors) or 90 days (survivors)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Gil Joon Suh, MD, PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
October 9, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 21, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1408-003-599
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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