Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department

NCT ID: NCT01947127

Last Updated: 2016-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 458 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Sepsis; Disease Progression; Septic Shock; Fatal Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High lactate

Initial venous lactate level equal to or more than 2.0 mmol/L

No interventions assigned to this group

Low lactate

Initial venous lactate level less than 2.0 mmol/L

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Khrongwong Musikatavorn, MD.

Khrongwong Musikatavorn, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khrongwong Musikatavorn, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Facalty of medicine, Chulalongkorn University

Locations

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 25936479 (View on PubMed)

Other Identifiers

793/2012

Identifier Type: -

Identifier Source: org_study_id