Sepsis-3 Study in Northeast Thailand

Launched by UNIVERSITY OF OXFORD · Dec 14, 2017

Keywords

ClinConnect Summary

The Sepsis-3 Study in Northeast Thailand is looking into how to better understand and treat sepsis, which is a serious condition caused by infections that can affect people who are hospitalized. The study will focus on adult patients who have been admitted to the hospital with community-acquired sepsis, meaning their infection was not caught in the hospital. To be eligible, participants need to be at least 18 years old, Thai nationals, and have a doctor confirm that an infection is the main reason for their hospital stay. They will also need to show signs of severe illness related to the infection.

Participants in this study can expect to have various samples taken, such as blood and urine, when they are admitted to the hospital. These samples will be used to identify the cause of their infection and help determine the best treatment. The researchers will monitor their care during the hospital stay and check in with them 28 days after discharge to see how they are doing. This study aims to improve our understanding of sepsis and help guide better treatment options for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females 18 years old.
• • 2. Thai nationality.
• • 3. Required hospitalization as decided by the attending physician
• • 4. 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).
• 5. 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 Criteria:
• • 1. 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.
• • 2. Hospitalized at the study site for this current episode for more than 24 hours before enrollment.
• • 3. Hospitalized for this current episode for more than 72 hours at another primary/referring hospital
• • 4. Prior to this current episode, the patient was admitted to any hospital within the last 30 days.
• • 5. 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.