Disease Progression, Fatal Outcome, Sepsis, Septic Shock
Conditions
Keywords
Lactate, Sepsis, Septic shock, Disease progression, Prognosis
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.
Interventions
None listed
Sponsors
Chulalongkorn University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality Rates | 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 | 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 |
Countries
Thailand
Participant flow
Recruitment details
Recruitment started at April 2013 to October 2014 at King Chulalongkorn Memorial Hospital, a university-affiliated, 1,500 bed, tertiary care urban hospital
Participants by arm
| Arm | Count |
|---|---|
| High Lactate Initial venous lactate level equal to or more than 2.0 mmol/L | 143 |
| Low Lactate Initial venous lactate level less than 2.0 mmol/L | 249 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data loss | 4 | 4 |
| Overall Study | Protocol Violation | 18 | 38 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | High Lactate | Low Lactate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants | 249 Participants | 392 Participants |
| Age, Continuous | 46.0 years STANDARD_DEVIATION 13.7 | 42.8 years STANDARD_DEVIATION 14.4 | 44.0 years STANDARD_DEVIATION 14.2 |
| Race/Ethnicity, Customized Thai and Southeast Asian | 143 participants | 249 participants | 392 participants |
| Region of Enrollment Thailand | 143 participants | 249 participants | 392 participants |
| Sex: Female, Male Female | 64 Participants | 120 Participants | 184 Participants |
| Sex: Female, Male Male | 79 Participants | 129 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 143 | 0 / 249 |
| serious Total, serious adverse events | 0 / 143 | 0 / 249 |
Outcome results
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.
Time frame: 72 hours after venous lactate measurement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Lactate | Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator | 53 participants |
| Low Lactate | Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator | 21 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.
Time frame: 30 days after the day of presentation to the emergency department
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Lactate | All-cause Mortality Rates | 18 participants |
| Low Lactate | All-cause Mortality Rates | 13 participants |
Secondary
Hospital Length of Stay
Numbers of days spent in the hospital since the emergency department arrival to hospital discharge
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Lactate | Hospital Length of Stay | 6 Days |
| Low Lactate | Hospital Length of Stay | 3 Days |