Severe Sepsis and Septic Shock Registry

Sepsis Clinical Trial

Official title:

Severe Sepsis and Septic Shock Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936232
• Other study ID #: 1408-003-599
• Status: Recruiting
• Start date: August 2014
• Est. completion date: March 2028

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Kyung Su Kim, MD, PhD
• Phone: 82-10-8033-1127
• Email: kanesu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul Metropolitan Government-Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (22)

Lead Sponsor

Collaborator

Seoul National University Hospital

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	According to hospital discharge record review and telephone follow-up.	28-day
Secondary	90-day mortality	According to hospital discharge record review and telephone follow-up.	90-day
Secondary	Organ support treatment (mechanical ventilation)	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
Secondary	Organ support treatment (renal replacement therapy)	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
Secondary	ICU length of stay	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)
Secondary	Hospital length of stay	According to hospital record review	hospital discharge (non-survivors) or 90 days (survivors)