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

Sepsis Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947127
• Other study ID #: 793/2012
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: June 2, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Progression
• Fatal Outcome
• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
Thailand	Emergency Medicine Unit, King Chulalongkorn Memorial Hospital	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	72 hours after venous lactate measurement	No
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.	30 days after the day of presentation to the emergency department	No
Secondary	Hospital Length of Stay	Numbers of days spent in the hospital since the emergency department arrival to hospital discharge	Patients will be followed for the duration of hospital stay, an expected average of 7 days	No