Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand

Conditions

Sepsis, Severe Sepsis

Brief summary

This is an observational study to identify the aetiology and factors associated with outcome of community-acquired sepsis and severe 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 and throat swabs) will be collected from each participant on admission for culture, PCR and serological tests, and other laboratory tests, including inflammatory markers and genotyping. 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. There will be a total of 5,020 patients enrolled in this study over 3 years.

Detailed description

Primary objective: To determine the causes of community-acquired sepsis and severe sepsis in NE Thailand. Secondary Objectives: 1. To define the clinical outcome of community-acquired sepsis and severe sepsis in NE Thailand. 2. To determine factors associated with inflammatory response, organ failure, and mortality in community-acquired sepsis and severe sepsis in NE Thailand, including causes of sepsis, sepsis resuscitation, antimicrobial treatment and genetic factors. 3. To evaluate diagnostic tests for infection in community-acquired sepsis and severe sepsis in NE Thailand. NOTE: THIS STUDY IS CO-SPONSORED BY 1. University of Oxford 2. University of Washington

Suchart Booraphun, Viriya Hantrakun, Suwatthiya Siriboon, Chaiyaporn Boonsri, Pulyamon Poomthong et al. (15 authors)

BMJ Open2021-02-0110 citations

10.1136/bmjopen-2020-041022

sTREM-1 predicts mortality in hospitalized patients with infection in a tropical, middle-income country.

Wright SW, Lovelace-Macon L, Hantrakun V, Rudd KE, Teparrukkul P, Kosamo S, Liles WC, Limmathurotsakul D, West TE.

2020-07-0135 citations

10.1186/s12916-020-01627-5

Early management of sepsis in medical patients in rural Thailand: a single-center prospective observational study.

Rudd KE, Hantrakun V, Somayaji R, Booraphun S, Boonsri C, Fitzpatrick AL, Day NPJ, Teparrukkul P, Limmathurotsakul D, West TE.

2019-12-0213 citations

10.1186/s40560-019-0407-z

Clinical epidemiology and outcomes of community acquired infection and sepsis among hospitalized patients in a resource limited setting in Northeast Thailand: A prospective observational study (Ubon-sepsis)

Viriya Hantrakun, Ranjani Somayaji, Prapit Teparrukkul, Chaiyaporn Boonsri, Kristina E. Rudd et al. (8 authors)

PLoS ONE2018-09-2649 citations

10.1371/journal.pone.0204509

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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) * Presence of any 3 of the following Systemic Inflammatory Response Syndrome (SIRS) * Fever or hypothermia (Core body temperature defined as \> 38.3 C or \< 36.0 C) * Tachycardia (heart rate \> 90 beats per minute) * Tachypnea (respiratory rate \> 20 per minute) * Arterial hypotension (systolic blood pressure (SBP) \< 90 mmHg, mean arterial pressure (MAP) \< 70 mmHg, or SBP decrease \> 40 mmHg) * White blood cell (WBC) \> 12,000/µL \< 4000/µL or immature forms \> 10% * Platelet count \< 100,000/microlitre * Altered mental status with Glasgow Coma Score (GCS) \< 15 * Hypoxemia (Pulse Oximetry Level \< 95) * Ileus * Significant edema or positive fluid balance * Decreased capillary refill or mottling * Hyperglycemia (plasma glucose \> 140 mg/dL) in the absence of diabetes * Plasma C-reactive protein \> 2 SD above the normal value * Plasma procalcitonin \> 2 SD above the normal value * Arterial hypoxemia (PaO2 / FIO2 \< 300) * Acute oliguria (urine output \< 0.5 mL/kg/hr or 45 mmol/L for 2 hours) * Creatinine increase \> 0.5 mg/dL * INR \> 1.5 or aPTT \> 60 seconds * Plasma total bilirubin \> 4 mg/dl or 70 mmol/L * Hyperlactatemia (\> 1 mmol/L)

Exclusion criteria

* Infection is not suspected to be a primary cause of the current illness episode leading to the hospitalization. For example, community-acquired sepsis or severe sepsis is considered to be due to stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma * Hospitalized at this 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 or severe sepsis Please note that the following conditions are not

Design outcomes

Primary

Measure	Time frame
Percentage of enrolled subjects specified by bacterial/viral infection	3 Years

Secondary

Measure	Time frame
Percentage of deaths caused by community-acquired sepsis and severe sepsis in Northeast Thailand	3 Years
Sensitivities and specificities of diagnostic tests for infection in community-acquired sepsis and severe sepsis in Northeast Thailand	3 Years

Countries

Thailand

Outcome results