Community-Acquired Infections, Sepsis
Conditions
Keywords
causes of community-acquired sepsis, diagnostic tests
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 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.
Interventions
OTHERSpecimens collection
On admission: Blood samples 30.01 mL and other specimens (if available) for culture and other diagnostics tests including sputum, throat swab, urine (midstream urine), and pus which is part of routine practice for patients with sepsis at study site. Day 3: Blood (15 mL) for culture (10 mL) and PCR (5 mL). There will be no blood collection, if patient is discharged before day 3.
Sponsors
Sanpasitthiprasong Hospital
Mahidol Oxford Tropical Medicine Research Unit
University of Oxford
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality after admission date | 2.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular: Dosages (μg/kg/min) of inotropic | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Causative organisms of community-acquired sepsis | 2.5 years | — |
| Respiration: Blood gas (PaO2 [mmHg]) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Respiration: Type of oxygen support | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Respiration: FiO2 (% ) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Respiration: SpO2 by pulse oximeter level (%) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Coagulation: Platelet (per μL) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Liver: Total Bilirubin (mg/dL) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Cardiovascular: Dosages (μg/kg/min) of vasopressor agents | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Cardiovascular: Mean Arterial Pressure (MAP) at enrolment (mmHg) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Renal: Creatinine (mg/sdL) | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
| Hematology | 2.5 years | Other laboratory measurement |
| Blood chemistry | 2.5 years | Other laboratory measurement |
| Causes of sepsis associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand | 2.5 years | — |
| Sepsis resuscitation associated 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 | — |
| Genetics factors 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 | — |
| Central nervous system: Glasgow Coma Score | 2.5 years | Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA) |
Countries
Thailand
Outcome results
None listed