Severe Sepsis and Septic Shock Registry

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: Sepsis

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

• 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

• Korea, Republic of
  • 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

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:

  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

Study Plan

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	According to hospital discharge record review and telephone follow-up.	28-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	According to hospital discharge record review and telephone follow-up.	90-day
Organ support treatment (mechanical ventilation)	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
Organ support treatment (renal replacement therapy)	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
ICU length of stay	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
Hospital length of stay	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Chonbuk National University Hospital; Samsung Medical Center; Asan Medical Center; Chonnam National University Hospital; Ulsan University Hospital; Korea University Anam Hospital; Seoul National University Bundang Hospital; Korea University Guro Hospital; Kyungpook National University Hospital; Inje University; Seoul National University Boramae Hospital; The Catholic University of Korea; Gangnam Severance Hospital; Severance Hospital; Hanyang University Seoul Hospital; Jeju National University Hospital; Hallym University Medical Center; Hallym University Kangnam Sacred Heart Hospital; Bucheon St. Mary's Hospital; Kyunghee University Medical Center; Chosun University Hospital
• Investigators: Study Director: Gil Joon Suh, MD, PhD, Seoul National University Hospital

Study record dates

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: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• 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