Severe Sepsis and Septic Shock Registry

Recruiting

• Conditions: Sepsis

• Registration Number: NCT02936232
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	28-day	According to hospital discharge record review and telephone follow-up.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Metropolitan Government-Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of