Registry for patients with severe sepsis and septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kanesu@gmail.com
• Phone: 82-10-8033-1127

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.