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Severe Sepsis and Septic Shock Registry

Severe Sepsis and Septic Shock Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02936232
Enrollment
3000
Registered
2016-10-18
Start date
2014-08-31
Completion date
2028-03-31
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

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.

Interventions

None listed

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
Seoul National University Boramae Hospital
CollaboratorOTHER
Hallym University Kangnam Sacred Heart Hospital
CollaboratorOTHER
Gangnam Severance Hospital
CollaboratorOTHER
Kyungpook National University Hospital
CollaboratorOTHER
Kyunghee University Medical Center
CollaboratorOTHER
Korea University Guro Hospital
CollaboratorOTHER
Korea University Anam Hospital
CollaboratorOTHER
The Catholic University of Korea
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Asan Medical Center
CollaboratorOTHER
Severance Hospital
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Inje University Ilsan Paik Hospital
CollaboratorOTHER
Chonnam National University Hospital
CollaboratorOTHER
Chonbuk National University Hospital
CollaboratorOTHER
Jeju National University Hospital
CollaboratorOTHER
Chosun University Hospital
CollaboratorOTHER
Hallym University Medical Center
CollaboratorOTHER
Hanyang University Seoul Hospital
CollaboratorOTHER
Bucheon St. Mary's Hospital
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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: 1. cardiovascular (hypotension, systolic blood pressure \<90 mmHg, mean arterial pressure \<70mmHg) 2. tissue hypoperfusion (lactate above upper limits laboratory normal) 3. acute lung injury (PaO2/inspired oxygen fraction \< 250 in the absence of pneumonia, PaO2/inspired oxygen fraction \< 200 in the presence of pneumonia) 4. acute kidney injury (Urine output \< 0.5mL/kg/hr for at least 2 hrs Serum creatinine \> 2.0 mg/dL) 5. acute liver injury (Total bilirubin \> 2mg/dL) 6. 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

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28-dayAccording to hospital discharge record review and telephone follow-up.

Secondary

MeasureTime frameDescription
90-day mortality90-dayAccording to hospital discharge record review and telephone follow-up.
Organ support treatment (mechanical ventilation)hospital discharge (non-survivors) or 90 days (survivors)According to hospital record review
Organ support treatment (renal replacement therapy)hospital discharge (non-survivors) or 90 days (survivors)According to hospital record review
ICU length of stayhospital discharge (non-survivors) or 90 days (survivors)According to hospital record review
Hospital length of stayhospital discharge (non-survivors) or 90 days (survivors)According to hospital record review

Countries

South Korea

Contacts

Primary ContactKyung Su Kim, MD, PhD
kanesu@gmail.com82-10-8033-1127
Backup ContactWoon Wong Kwon, MD, PhD
kwy711@hanmail.net82-2-2072-4751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026