NCT03379402已完成不适用
Utility of Sepsis-3 Definition, Causes and Factors Associated With Outcomes in Community-acquired Sepsis in Ubon Ratchathani, Northeast Thailand
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- 28-day mortality after admission date
研究概览
简要总结
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 with outcome of community-acquired sepsis in Northeast Thailand.
Potential study participants will be adult patients who are presented at the hospital with community-acquired sepsis. Clinical specimens (including blood, urine, sputum, throat swabs and pus or wound swab) will be collected from each participant on admission for culture, PCR and serological tests, and other laboratory tests. Participants' treatment will be closely monitored during the duration of their hospital stay. Blood will be again collected at 72 hours after admission. Participants will be contacted at 28 days after admission to determine clinical outcome by phone interview with standardized script.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Adult patients presenting with sepsis
Adult patients, both males and females, presenting with sepsis will be approached for participation in the study.
干预措施: Specimens collection (Other)
结局指标
主要结局
28-day mortality after admission date
时间窗: 2.5 years
次要结局
- Causative organisms of community-acquired sepsis(2.5 years)
- Respiration: FiO2 (% )(2.5 years)
- Causes of sepsis associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand(2.5 years)
- Respiration: Type of oxygen support(2.5 years)
- Blood chemistry(2.5 years)
- Respiration: Blood gas (PaO2 [mmHg])(2.5 years)
- Coagulation: Platelet (per μL)(2.5 years)
- Cardiovascular: Dosages (μg/kg/min) of inotropic(2.5 years)
- Cardiovascular: Dosages (μg/kg/min) of vasopressor agents(2.5 years)
- Central nervous system: Glasgow Coma Score(2.5 years)
- Renal: Creatinine (mg/sdL)(2.5 years)
- Hematology(2.5 years)
- Sepsis resuscitation associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand(2.5 years)
- Cardiovascular: Mean Arterial Pressure (MAP) at enrolment (mmHg)(2.5 years)
- Respiration: SpO2 by pulse oximeter level (%)(2.5 years)
- Liver: Total Bilirubin (mg/dL)(2.5 years)
- Genetics factors with mortality outcome in patients with community-acquired sepsis in northeast Thailand(2.5 years)
- Antimicrobial treatment associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand(2.5 years)
- Inflammatory associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand(2.5 years)
- Diagnostic tests for infection in community-acquired sepsis in NE Thailand(2.5 years)
研究者
研究点 (1)
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