Clinical trial NCT01947127: Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Disease Progression
Septic Shock
Fatal Outcome
Keywords: Lactate
Sepsis
Septic shock
Disease progression
Prognosis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department patients of King Chulalongkorn Memorial Hospital (a 1500-bed, tertiary-care, university-affiliated urban hospital)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator
timeFrame: 72 hours after venous lactate measurement
Secondary outcomes:
measure: All-cause Mortality Rates
timeFrame: 30 days after the day of presentation to the emergency department
measure: Hospital Length of Stay
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Department of Medicine, Facalty of medicine, Chulalongkorn University
name: Khrongwong Musikatavorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.