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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Sepsis; Disease Progression; Septic Shock; Fatal Outcome

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.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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

Venous blood lactate obtained by standard venipuncture together with other essential blood works before giving antibiotics or intravenous fluid, if required. Lactate level is measured by Epoc® point-of-care blood analyzer (Epocal Inc., Ottawa, ON, Canada) within 5 minutes after obtaining the venous sample without any preservative.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Emergency department patients of King Chulalongkorn Memorial Hospital (a 1500-bed, tertiary-care, university-affiliated urban hospital)

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Thailand
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 11130

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:	Khrongwong Musikatavorn, MD	Department of Medicine, Facalty of medicine, Chulalongkorn University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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
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