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

NCT01947127 | Completed Results DMC

• 1 other identifier: 793/2012
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Disease Progression; Septic Shock; Fatal Outcome

Keywords

Lactate; Sepsis; Septic shock; Disease progression; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• All-cause Mortality Rates

  30 days after the day of presentation to the emergency department

• Hospital Length of Stay

  Patients will be followed for the duration of hospital stay, an expected average of 7 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 11130, Thailand

Location

Related 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: 10.1016/j.ajem.2015.04.010. Epub 2015 Apr 10.

  PMID: 25936479 RESULT

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.

MeSH Terms

Conditions

Sepsis; Disease Progression; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Shock

Limitations and Caveats

1\. This was an observational study that did not evaluate the aggressiveness of the treatment strategies. 2. The study was done in a single, urban, university hospital. 3. The staging of co-morbidity (e.g. cancers) was not well-categorized.

Results Point of Contact

• Title: Khrongwong Musikatavorn, M.D.
• Organization: Faculty of Medicine, Chulalongkorn University

kmusikatavorn@yahoo.com

+6622564553

Study Officials

• Khrongwong Musikatavorn, MD

  Department of Medicine, Facalty of medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Khrongwong Musikatavorn, MD

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 20, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 2, 2016
• Results First Posted: May 7, 2015

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)