An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
NCT ID: NCT02157259
Last Updated: 2016-02-18
Study Results
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Basic Information
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COMPLETED
2250 participants
OBSERVATIONAL
2013-12-31
2016-02-29
Brief Summary
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Detailed Description
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Primary objective of the study is to determine the causes of community-acquired sepsis and severe sepsis in adult and pediatric subjects across Southeast Asia.
The secondary objectives are as follow:
* To define the current acute management (within the first 48 hours after admission) of subjects presenting with community-acquired sepsis and severe sepsis and gaps of current practice as defined by the surviving sepsis campaign 2012. This will provide the basis for designing practical interventions to reduce the mortality of subjects with sepsis and severe sepsis in the future.
* To define the clinical outcomes of community-acquired sepsis and severe sepsis in Southeast Asia.
* To identify risk factors associated with sepsis or severe sepsis.
* To determine the extent of antimicrobial resistance in organisms that cause community-acquired sepsis and severe sepsis in Southeast Asia and to determine the association between antimicrobial resistance and mortality.
* To evaluate the accuracy of selected rapid diagnostic tests (RDTs) in determining the causes of community-acquired sepsis and severe sepsis compared to well-defined gold standard tests.
As this is an observational study and not a clinical trial, researchers will not be involved in the management, care and treatment of study subjects. This will remain the responsibility of the attending medical staff according to standard of care (SOC) in the participating hospitals. Therefore the research study will not influence patient management. SOC for sepsis and severe sepsis in each subject will be recorded, and will be reported as summary statistics at the end of the study. This will not be used to influence the management and care of sepsis and severe sepsis cases at the participating hospitals during the study period, but will be used to guide the improvement of the SOC after the study is complete.
NOTE: EACH INSTITUTION IN THIS STUDY IS ITS OWN SPONSOR AS LISTED BELOW:
1. Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
2. Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
3. Children's Hospital 1 Ho Chi Minh City, Vietnam.
4. Children's Hospital 2 Ho Chi Minh City, Vietnam.
5. Hospital for Tropical Diseases Ho Chi Minh City, Vietnam.
6. National Hospital for Pediatrics Hanoi, Vietnam.
7. National Hospital for Tropical Diseases, Hanoi, Vietnam.
8. Hue Central Hospital, Hue City, Vietnam.
9. Dr. Wahidin Soedirohusodo Hospital Makassar, Indonesia.
10. Dr. Sardjito Hospital Yogyakarta, Indonesia.
11. Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
12. Sappasithiprasong Hospital Ubonratchathani, Thailand
13. Chiangrai Prachanukroh Hospital, Chiangrai Thailand
14. University of Oxford, United Kingdom
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
* 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.
30 Days
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
FHI 360
OTHER
Social & Scientific Systems Inc.
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Direk Limmathurotsakul, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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Dr. Sardjito Hospital
Yogyakarta, DI Yogyakarta, Indonesia
Cipto Mangunkusumo Hospital
Jakarta, DKI Jaya, Indonesia
Universitas Hasanuddin
Makassar, South Sulawesi, Indonesia
Dr. Wahidin Soedirohusodo
Makassar, South Sulawesi, Indonesia
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Bangkok, Bangkok, Thailand
Pediatric Unit Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Bangkok, Bangkok, Thailand
Queen Sirikit National Institute of Child Health
Bangkok, Bangkok, Thailand
Sappasitthiprasong Hospital
Ubon Ratchathani, Changwat Ubon Ratchathani, Thailand
Chiangrai Prachanukroh Hospital
Chiangrai, Chiangrai, Thailand
National Hospital of Paediatric
Hanoi, Hanoi, Vietnam
National Hospital of Tropical Diseases
Hanoi, Hanoi, Vietnam
Children Hospital 1
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Children Hospital 2
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Hospital of Tropical Diseases
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Hue Central Hospital
Huế, Hue City, Vietnam
Countries
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References
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World Health Organization (2008) The global burden of disease: 2004 update.
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.
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Limmathurotsakul D, Wongratanacheewin S, Teerawattanasook N, Wongsuvan G, Chaisuksant S, Chetchotisakd P, Chaowagul W, Day NP, Peacock SJ. Increasing incidence of human melioidosis in Northeast Thailand. Am J Trop Med Hyg. 2010 Jun;82(6):1113-7. doi: 10.4269/ajtmh.2010.10-0038.
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Kanoksil M, Jatapai A, Peacock SJ, Limmathurotsakul D. Epidemiology, microbiology and mortality associated with community-acquired bacteremia in northeast Thailand: a multicenter surveillance study. PLoS One. 2013;8(1):e54714. doi: 10.1371/journal.pone.0054714. Epub 2013 Jan 18.
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West TE CN, Chierakul W, Limmathurotsakul D, Wuthiekanun V, Myers ND, Emond MJ, Wurfel MM, Hawn TR, Peacock SJ, Skerrett SJ. A hypofunctional TLR5 is genetic variant is associated with survival in meliodosis. 2011
Lie KC, Lau CY, Van Vinh Chau N, West TE, Limmathurotsakul D; for Southeast Asia Infectious Disease Clinical Research Network. Utility of SOFA score, management and outcomes of sepsis in Southeast Asia: a multinational multicenter prospective observational study. J Intensive Care. 2018 Feb 14;6:9. doi: 10.1186/s40560-018-0279-7. eCollection 2018.
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Other Identifiers
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SEA-050 Sepsis Study
Identifier Type: -
Identifier Source: org_study_id
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