Severe Sepsis and Septic Shock Registry

Seoul National University

Status: Enrolling

Conditions: Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT02936232

1408-003-599

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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