N/A
N=458
Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department
Sepsis · Disease Progression · Septic Shock · Fatal Outcome
Bottom Line
View on ClinicalTrials.gov: NCT01947127 ↗Enrolled (actual)
458
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator — 53; 21 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chulalongkorn University
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator |
53; 21 | — |
| SECONDARY All-cause Mortality Rates |
18; 13 | — |
| SECONDARY Hospital Length of Stay |
6; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01947127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.