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Recruiting

NCT Number: NCT02936232

Severe Sepsis and Septic Shock Registry

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • cardiovascular (hypotension, systolic blood pressure <90 mmHg, mean arterial pressure <70mmHg)
  • tissue hypoperfusion (lactate above upper limits laboratory normal)
  • acute lung injury (PaO2/inspired oxygen fraction < 250 in the absence of pneumonia, PaO2/inspired oxygen fraction < 200 in the presence of pneumonia)
  • acute kidney injury (Urine output < 0.5mL/kg/hr for at least 2 hrs Serum creatinine > 2.0 mg/dL)
  • acute liver injury (Total bilirubin > 2mg/dL)
  • 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

Treatment and study plan

Primary outcomes

  1. 28-day mortality

    Time frame: 28-day

    According to hospital discharge record review and telephone follow-up.

Secondary outcomes

  1. 90-day mortality

    Time frame: 90-day

    According to hospital discharge record review and telephone follow-up.

  2. Organ support treatment (mechanical ventilation)

    Time frame: hospital discharge (non-survivors) or 90 days (survivors)

    According to hospital record review

  3. Organ support treatment (renal replacement therapy)

    Time frame: hospital discharge (non-survivors) or 90 days (survivors)

    According to hospital record review

  4. ICU length of stay

    Time frame: hospital discharge (non-survivors) or 90 days (survivors)

    According to hospital record review

  5. Hospital length of stay

    Time frame: hospital discharge (non-survivors) or 90 days (survivors)

    According to hospital record review

Study contacts

Contact information is provided by the study sponsor or research team.

Kyung Su Kim, MD, PhD

CONTACT

[email protected]

82-10-8033-1127

Woon Wong Kwon, MD, PhD

CONTACT

[email protected]

82-2-2072-4751

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2016
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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