NCT02936232

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Aug 2014Mar 2028

Study Start

First participant enrolled

August 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

13.6 years

First QC Date

October 9, 2016

Last Update Submit

November 21, 2023

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    According to hospital discharge record review and telephone follow-up.

    28-day

Secondary Outcomes (5)

  • 90-day mortality

    90-day

  • Organ support treatment (mechanical ventilation)

    hospital discharge (non-survivors) or 90 days (survivors)

  • Organ support treatment (renal replacement therapy)

    hospital discharge (non-survivors) or 90 days (survivors)

  • ICU length of stay

    hospital discharge (non-survivors) or 90 days (survivors)

  • Hospital length of stay

    hospital discharge (non-survivors) or 90 days (survivors)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe sepsis or septic shock

You may qualify if:

  • 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)

You may not qualify if:

  • age less than 18 years old
  • patients with cardiac arrest at presentation
  • patients with advanced directives not to deliver aggressive organ supportive management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110714, South Korea

RECRUITING

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gil Joon Suh, MD, PhD

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Kyung Su Kim, MD, PhD

CONTACT

82-10-8033-1127kanesu@gmail.com

Woon Wong Kwon, MD, PhD

CONTACT

82-2-2072-4751kwy711@hanmail.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2016

First Posted

October 18, 2016

Study Start

August 1, 2014

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

KR(3)