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

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ClinicalTrials.gov Identifier: NCT02217592
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborators:
Wellcome Trust
National Institutes of Health (NIH)
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease
Sepsis Severe Sepsis

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

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Study Type : Observational
Actual Enrollment : 5020 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast (NE) Thailand
Actual Study Start Date : May 20, 2012
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. Percentage of enrolled subjects specified by bacterial/viral infection [ Time Frame: 3 Years ]

Secondary Outcome Measures :
  1. Percentage of deaths caused by community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]
  2. Sensitivities and specificities of diagnostic tests for infection in community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
Blood. Urine, pus, sputum, throat swab, and stool (if available)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female patients, 18 years old with community-acquired sepsis or severe sepsis in Northeast Thailand
Criteria

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 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 48 hours prior to enrollment
  • Patients fulfilling the inclusion criteria without having result of complete blood count or result of all parameters in the inclusion criteria. For example, a patient who has hypothermia, tachycardia and tachypnea completes the criteria of SIRS even without the result of complete blood count or the result of other parameters such as INR, or plasma procalcitonin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217592


Locations
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Thailand
Sappasithiprasong Hospital
Ubon Ratchathani, Thailand, 34000
Sponsors and Collaborators
University of Oxford
Wellcome Trust
National Institutes of Health (NIH)
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Dr.Direk Limmathurotsakul Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02217592     History of Changes
Other Study ID Numbers: MICRO1206
1R01HL113382 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes