Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department
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ClinicalTrials.gov Identifier: NCT01947127 |
Recruitment Status
:
Completed
First Posted
: September 20, 2013
Results First Posted
: May 7, 2015
Last Update Posted
: December 2, 2016
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Condition or disease |
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Sepsis Disease Progression Septic Shock Fatal Outcome |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 458 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Month |
Official Title: | Can Venous Lactate Predict the Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients Without Hemodynamic Shock in Emergency Department? |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | January 2015 |
Group/Cohort |
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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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- Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator [ Time Frame: 72 hours after venous lactate measurement ]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.
- All-cause Mortality Rates [ Time Frame: 30 days after the day of presentation to the emergency department ]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.
- Hospital Length of Stay [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 7 days ]Numbers of days spent in the hospital since the emergency department arrival to hospital discharge
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18 to 65 years
- Confirmed or suspected diagnoses of acute infections (within 7 days)
- Major infections (e.g. Acute pyelonephritis, Acute bronchitis/pneumonia, Acute hepatobiliary tract infections, intrabdominal abscesses, meningitis and other central nervous system infections, soft tissue infections involving more than 10 square centimeters of the skin surface or deeper down beyond the dermis, significant tropical infections; dengue fever, leptospirosis, typhus fevers, or high fever from any infectious sources)
- Systolic blood pressure more than 90 mmHg at presentation
- Mean arterial pressure more than 70 mmHg at presentation
Exclusion Criteria:
- Duplicated cases that have participated in this study during the study period
- Overt organ hypoperfusion (e.g. cold, clammy or mottling skin, altered mental status; Glasgow Coma Scale equal to or less than 12 or decrease > 1 compared with the baseline)
- Pulse oximetry equal to or less than 90% at ambient air
- received intravenous fluid more than 10 ml/kg prior to the venous blood sampling
- received intravenous antibiotics for more than 1 hours prior to the venous blood sampling
- Minor infections (e.g. uncomplicated upper respiratory tract infections, gastroenteritis, minor skin infections)
- currently taking antiretroviral drugs
- having or suspicious of having seizures in the past 72 hours

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): NCT01947127
Thailand | |
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital | |
Patumwan, Bangkok, Thailand, 11130 |
Principal Investigator: | Khrongwong Musikatavorn, MD | Department of Medicine, Facalty of medicine, Chulalongkorn University |
Publications of Results:
Responsible Party: | Khrongwong Musikatavorn, MD., Khrongwong Musikatavorn, MD, Chulalongkorn University |
ClinicalTrials.gov Identifier: | NCT01947127 History of Changes |
Other Study ID Numbers: |
793/2012 |
First Posted: | September 20, 2013 Key Record Dates |
Results First Posted: | May 7, 2015 |
Last Update Posted: | December 2, 2016 |
Last Verified: | April 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Khrongwong Musikatavorn, MD., Chulalongkorn University:
Lactate Sepsis Septic shock Disease progression Prognosis |
Additional relevant MeSH terms:
Emergencies Sepsis Toxemia Shock Disease Progression Shock, Septic |
Disease Attributes Pathologic Processes Infection Systemic Inflammatory Response Syndrome Inflammation |