Severe Sepsis and Septic Shock Registry

NCT ID: NCT02936232

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2028-03-31

Brief Summary

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The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.

Detailed Description

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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

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Inje University Ilsan Paik Hospital

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role collaborator

Jeju National University Hospital

OTHER

Sponsor Role collaborator

Chosun University Hospital

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Hanyang University Seoul Hospital

OTHER

Sponsor Role collaborator

Bucheon St. Mary's Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gil Joon Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gil Joon Suh, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Su Kim, MD, PhD

Role: CONTACT

82-10-8033-1127

Woon Wong Kwon, MD, PhD

Role: CONTACT

82-2-2072-4751

Facility Contacts

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You Hwan Jo, MD, PhD

Role: primary

(82)-31-787-7574

Kyung Su Kim, MD, PhD

Role: primary

82-10-8033-1127

Huijai Lee, MD

Role: primary

82-2-870-2664

Other Identifiers

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1408-003-599

Identifier Type: -

Identifier Source: org_study_id