Clinical trial NCT02936232: Severe Sepsis and Septic Shock Registry
Official title: Severe Sepsis and Septic Shock Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: Hallym University Kangnam Sacred Heart Hospital
name: Gangnam Severance Hospital
name: Kyungpook National University Hospital
name: Kyunghee University Medical Center
name: Korea University Guro Hospital
name: Korea University Anam Hospital
name: The Catholic University of Korea
name: Samsung Medical Center
name: Asan Medical Center
name: Severance Hospital
name: Ulsan University Hospital
name: Inje University Ilsan Paik Hospital
name: Chonnam National University Hospital
name: Chonbuk National University Hospital
name: Jeju National University Hospital
name: Chosun University Hospital
name: Hallym University Medical Center
name: Hanyang University Seoul Hospital
name: Bucheon St. Mary's Hospital
First posted: 2016-10-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe sepsis or septic shock

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28-day
Secondary outcomes:
measure: 90-day mortality
timeFrame: 90-day
measure: Organ support treatment (mechanical ventilation)
timeFrame: hospital discharge (non-survivors) or 90 days (survivors)
measure: Organ support treatment (renal replacement therapy)
timeFrame: hospital discharge (non-survivors) or 90 days (survivors)
measure: ICU length of stay
timeFrame: hospital discharge (non-survivors) or 90 days (survivors)
measure: Hospital length of stay
timeFrame: hospital discharge (non-survivors) or 90 days (survivors)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Gil Joon Suh, MD, PhD
role: STUDY_DIRECTOR
References: