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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Khrongwong Musikatavorn, MD., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01947127
First received: September 10, 2013
Last updated: September 17, 2013
Last verified: January 2013
  Purpose

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
Sepsis
Disease Progression
Septic Shock
Fatal Outcome

Study Type: Observational [Patient Registry]
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Proportion of the patients who require vasopressor/mechanical ventilator [ Time Frame: 72 hours after venous lactate measurement ] [ Designated as safety issue: No ]
    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:
  • All-cause mortality rates [ Time Frame: 30 days after the day of presentation to the emergency department ] [ Designated as safety issue: No ]
    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 [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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, intraabdominal 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947127

Contacts
Contact: Khrongwong Musikatavorn, MD +66818390511 kmusikatavorn@yahoo.com
Contact: Saranpat Thepnimitra, MD +66875800916 docpup9@hotmail.com

Locations
Thailand
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital Recruiting
Patumwan, Bangkok, Thailand, 11130
Contact: Khrongwong Musikatavorn, MD    +66818390511    kmusikatavorn@yahoo.com   
Contact: Saranpat Thepnimitra, MD    +66875800916    docpup9@hotmail.com   
Principal Investigator: Khrongwong Musikatavorn, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Khrongwong Musikatavorn, MD Department of Medicine, Facalty of medicine, Chulalongkorn University
  More Information

No publications provided

Responsible Party: Khrongwong Musikatavorn, MD., Khrongwong Musikatavorn, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01947127     History of Changes
Other Study ID Numbers: 793/2012
Study First Received: September 10, 2013
Last Updated: September 17, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Lactate
Sepsis
Septic shock
Disease progression
Prognosis

Additional relevant MeSH terms:
Shock
Shock, Septic
Emergencies
Sepsis
Toxemia
Disease Progression
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 21, 2014