Registry for patients with severe sepsis and septic shock

Severe Sepsis and Septic Shock Registry

This study is collecting information from adults with severe sepsis or septic shock in emergency departments to help improve treatment and reduce deaths from this condition.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 3 sites (Seongnam-si, Gyeonggi-do and 2 other locations)
• Trial ID: NCT02936232 on ClinicalTrials.gov

What this trial studies

This registry aims to enroll adult patients experiencing severe sepsis or septic shock across 21 tertiary hospital emergency departments. By collecting and storing data on these patients, the registry will facilitate quality control and clinical research efforts aimed at reducing mortality associated with sepsis. The data gathered will be used to improve understanding and treatment of sepsis in clinical settings.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who meet specific criteria for severe sepsis or septic shock.

Not a fit: Patients under 18 years old or those with cardiac arrest will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved treatment protocols and reduced mortality rates for patients suffering from sepsis.

How similar studies have performed: Other studies utilizing similar registry approaches have shown promise in improving patient outcomes in sepsis management.

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

Where this trial is running

Seongnam-si, Gyeonggi-do and 2 other locations

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Kyung Su Kim, MD, PhD

Conditions Sepsis