Status:
UNKNOWN
Sepsis-3 Study in Northeast Thailand
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Sanpasitthiprasong Hospital
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Sepsis
Community-Acquired Infections
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study to evaluate the utility of the latest recommendation to define severity of infection for sepsis patients (sepsis-3), and to identify the aetiology and factors associated...
Eligibility Criteria
Inclusion
- Males and females 18 years old.
- Thai nationality.
- Required hospitalization as decided by the attending physician
- Documented by attending physician that an infection is the primary cause of illness leading to the hospitalization. These can be infections due to any pathogens (bacteria, viruses, fungi and parasites).
- qSOFA (quick Sepsis-related Organ Failure Assessment) score ≥ 2 defined as 2 or more of the following:
- Respiratory rate ≥22 /min or required ventilator
- Alteration of mental status (GCS\<15 or 10T with endotracheal tube)
- Systolic blood pressure ≤100 mm Hg
Exclusion
- Infection is not suspected to be a primary cause of the current illness episode leading to the hospitalization. For example, community-acquired sepsis is considered to be due to stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma.
- Hospitalized at the study site for this current episode for more than 24 hours before enrollment.
- Hospitalized for this current episode for more than 72 hours at another primary/referring hospital
- Prior to this current episode, the patient was admitted to any hospital within the last 30 days.
- Prior to enrolment, it is documented by the attending physician that hospital acquired infection is associated with the cause of sepsis.
- Please note that the following conditions are not exclusion criteria, and patients with the following conditions can be enrolled into the study.
- Confirmed diagnosis by any method of an infection as a major cause of illnesses leading to hospitalization. For example, a patient who already has had a definite diagnosis of malarial infection by blood smear.
- Clinical diagnosis of any specific disease or any specific syndromes such as acute infective diarrhea, acute pneumonia, acute encephalomyelitis and acute myocarditis.
- Suspected of having both infectious and non-infectious diseases and infectious disease is a primary cause of illnesses (primary diagnosis) leading to the hospitalization. For example, acute pneumonia with stroke as an underlying disease, etc.
- Patients who are admitted to other hospitals and referred to the study site. For example a referred patient who admit to the first hospital less than 24 hours prior to enrollment.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT03379402
Start Date
February 1 2018
End Date
December 31 2024
Last Update
August 2 2022
Active Locations (1)
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1
Sappasithiprasong Hospital
Ubon Ratchathani, Thailand, 34000