An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02157259
• Date of registration: 20/05/2014
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia SEA050
• Scientific title: An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
• Date of first enrolment: December 2013
• Target sample size: 2250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02157259
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Indonesia, Thailand, Vietnam

Contacts

• Name: Direk Limmathurotsakul, MD
• Affiliation: Mahidol Oxford Tropical Medicine Research Unit (MORU), Thailand

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =30 days old and weighing at least 3 kg or more on the day of enrollment into the
study

2. Required hospitalization as decided by the attending physician

3. 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).

4. Presence of Systemic Inflammatory Response Syndrome (SIRS):

4.1 For adults (= 18 years old), any combination of a minimum of any 3 of the
following 20 parameters

- 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 u/L or <4000 u/L or immature forms >10%

- Platelet count <100,000 u/L

- 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 a PTT >60 seconds

- Plasma total bilirubin >4 mg/dl or 70 mmol/L

- Hyperlactatemia (>1 mmol/L)

4.2 For pediatric patients (>30 days old and <18 years old), all of the 3 following
symptoms:

- Fever or hypothermia (rectal temperature defined as >38.5 C or <35.0 C [or
equivalent])

- Tachycardia (heart rate >2 SD above the normal value for age). This could be
absent in hypothermic subject.

- Tachypnea (respiratory rate >2 SD above the normal value for age)

AND at least one of the following parameters:

- Altered mental status,(e.g., drowsiness, poor quality of cry, poor reaction to
parent stimuli, and poor response to social overtures)

- Systolic blood pressure <2 SD below the normal value for age OR narrow pulse
pressure (<20 mmHg) OR poor perfusion (capillary refill >2 sec)

- Hypoxemia (Pulse Oximetry Level <95)

- White blood cell >15,000 u/L or <5,000 u/L or immature forms >10%.

5. Informed Consent has been obtained.

Exclusion Criteria:

- Admitted to the study site hospital 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 subject was admitted to any hospital within the
last 30 days.

- An underlying pre-existing condition is thought to have led to or contributed to this
sepsis episode. For example, sepsis is considered to be directly attributable to
existing non-infectious conditions such as stroke, cardiovascular diseases, acute
myocardial infarction, cancer, burn, injury, and trauma.

- Prior to enrollment, it is documented by the attending physician that hospital
acquired infection is associated with the cause of the sepsis or severe sepsis.

- The subject has been enrolled into this study or another sepsis study before.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sepsis

Severe Sepsis

Primary Outcome(s)

The etiology of community-acquired sepsis and severe sepsis expressed in percentages of enrolled subjects. [Time Frame: Total length of time that subjects will be in the study is 28 to 35 days.]

Secondary Outcome(s)

Percentage of subjects receiving low-volume lung-protective ventilation. [Time Frame: 2 years]

Percentage of subjects receiving stress prophylaxis. [Time Frame: 2 years]

28-day mortality rate. [Time Frame: 2 years]

Percentage of initial systemic antimicrobial effective to treat the cause of the infection. [Time Frame: 2 years]

Percentage of subjects receiving renal replacement therapies (including hemodialysis and peritoneal dialysis). [Time Frame: 2 years]

Percentage of subjects receiving arterial blood gas evaluation). [Time Frame: 2 years]

Percentage of subjects receiving fluid challenge (giving bolus of fluid) if the patient has hypotension. [Time Frame: 2 years]

Percentage of patients receiving deep vein thrombosis (DVT) prophylaxis. [Time Frame: 2 years]

Percentage of subjects receiving adequate ventilatory support (including percentage of subjects receiving supplemental oxygen, percentage of subjects receiving Positive-end Expiratory Pressure (PEEP). [Time Frame: 2 years]

Percentage of subjects receiving evaluation by scoring system. [Time Frame: 2 years]

Percentage of subjects receiving imaging to determine source or deep foci of infection (including chest radiography, ultrasonogram, CT scan and MRI). [Time Frame: 2 years]

Prevalence of antimicrobial resistance and its association with appropriate empirical therapy and outcomes. [Time Frame: 2 years]

Risk factors associated with sepsis or severe sepsis [Time Frame: 2 years]

Sensitivities and specificities of selected RDTs in determining the causes of community-acquired sepsis and severe sepsis [Time Frame: 2 years]

Percentage of subjects developing major organ dysfunction; for example ventilatory failure and renal failure. [Time Frame: 2 years]

The time from hospital admission to any systemic antibiotic administration. [Time Frame: 2 years]

Percentage of subjects receiving treatment in ICUs. [Time Frame: 2 years]

Secondary ID(s)

SEA-050 Sepsis Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

Social & Scientific Systems Inc.

FHI 360