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To investigate the role of initial venous lactate in predicting the severity progression to overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who suspected to have acute infections.
Blood lactate is one of the markers that can predict the organ failures and mortality in emergency department (ED) patients with sepsis. Regarding its predictive role in the clinical deterioration in normotensive sepsis patients, a recent prospective observational study of the patients with moderately-high serum lactate (2.0-3.9 mmol/L) showed that one-forth of the patients eventually developed progressive organ dysfunctions or required vasopressor or mechanical ventilator. Unfortunately, low serum lactate (< 2.5 mmol/L) was still found up to 50% of overt septic shock patients, even in vasopressor-dependent cases. For the prognostic role on mortality, numbers of articles showed that blood lactate can also predict death in sepsis patients, especially in those who are elderly and critically-ill. However, no previous study was done in younger patients since lactate kinetics in the body may differ among the age groups. The primary aim of our study is to investigate the role of initial venous lactate levels in predicting the chance of severity progression to overt septic shock especially in non-elderly patients who suspected to have acute infections and without hemodynamic shock in ED. The secondary outcomes are to evaluate its prognostic role on hospital length of stay and 30-day mortality of this target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High lactate | Initial venous lactate level equal to or more than 2.0 mmol/L | ||
| Low lactate | Initial venous lactate level less than 2.0 mmol/L |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator | Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement. | 72 hours after venous lactate measurement |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Rates | Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis. | 30 days after the day of presentation to the emergency department |
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Inclusion Criteria:
Exclusion Criteria:
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Emergency department patients of King Chulalongkorn Memorial Hospital (a 1500-bed, tertiary-care, university-affiliated urban hospital)
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| Name | Affiliation | Role |
|---|---|---|
| Khrongwong Musikatavorn, MD | Department of Medicine, Facalty of medicine, Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medicine Unit, King Chulalongkorn Memorial Hospital | Patumwan | Bangkok | 11130 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25936479 | Result | Musikatavorn K, Thepnimitra S, Komindr A, Puttaphaisan P, Rojanasarntikul D. Venous lactate in predicting the need for intensive care unit and mortality among nonelderly sepsis patients with stable hemodynamic. Am J Emerg Med. 2015 Jul;33(7):925-30. doi: 10.1016/j.ajem.2015.04.010. Epub 2015 Apr 10. |
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Recruitment started at April 2013 to October 2014 at King Chulalongkorn Memorial Hospital, a university-affiliated, 1,500 bed, tertiary care urban hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | High Lactate | Initial venous lactate level equal to or more than 2.0 mmol/L |
| FG001 | Low Lactate | Initial venous lactate level less than 2.0 mmol/L |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Lactate | Initial venous lactate level equal to or more than 2.0 mmol/L |
| BG001 | Low Lactate | Initial venous lactate level less than 2.0 mmol/L |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator | Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement. | Posted | Number | participants | 72 hours after venous lactate measurement |
|
Overall study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Lactate | Initial venous lactate level equal to or more than 2.0 mmol/L |
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1. This was an observational study that did not evaluate the aggressiveness of the treatment strategies. 2. The study was done in a single, urban, university hospital. 3. The staging of co-morbidity (e.g. cancers) was not well-categorized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Khrongwong Musikatavorn, M.D. | Faculty of Medicine, Chulalongkorn University | +6622564553 | kmusikatavorn@yahoo.com |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D018450 | Disease Progression |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Venous blood lactate obtained by standard venipuncture together with other essential blood works before giving antibiotics or intravenous fluid, if required. Lactate level is measured by Epoc® point-of-care blood analyzer (Epocal Inc., Ottawa, ON, Canada) within 5 minutes after obtaining the venous sample without any preservative.
| Hospital Length of Stay | Numbers of days spent in the hospital since the emergency department arrival to hospital discharge | Patients will be followed for the duration of hospital stay, an expected average of 7 days |
| Data loss |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | All-cause Mortality Rates | Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis. | Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis. | Posted | Number | participants | 30 days after the day of presentation to the emergency department |
|
|
|
| Secondary | Hospital Length of Stay | Numbers of days spent in the hospital since the emergency department arrival to hospital discharge | Posted | Median | Inter-Quartile Range | Days | Patients will be followed for the duration of hospital stay, an expected average of 7 days |
|
|
|
| 0 |
| 143 |
| 0 |
| 143 |
| EG001 | Low Lactate | Initial venous lactate level less than 2.0 mmol/L | 0 | 249 | 0 | 249 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D012769 | Shock |