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Recruiting NCT02936232

Severe Sepsis and Septic Shock Registry

— Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 28-day mortality [Time frame: 28-day]
Secondary outcome measures (5)
  • 90-day mortality [Time frame: 90-day]
  • Organ support treatment (mechanical ventilation) [Time frame: hospital discharge (non-survivors) or 90 days (survivors)]
  • Organ support treatment (renal replacement therapy) [Time frame: hospital discharge (non-survivors) or 90 days (survivors)]
  • ICU length of stay [Time frame: hospital discharge (non-survivors) or 90 days (survivors)]
  • Hospital length of stay [Time frame: hospital discharge (non-survivors) or 90 days (survivors)]

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 3 centers
  • Seoul National University Bundang Hospital — Seongnam-si
  • Seoul National University Hospital — Seoul
  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul

Identifiers

NCT: NCT02936232 · 1408-003-599

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗