Recruitment

Recruitment Status
Terminated
Estimated Enrollment
60

Inclusion Criteria

Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
Tachycardia (heart rate > 90 bpm)
Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
...
Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
Tachycardia (heart rate > 90 bpm)
Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
ICU patients with new onset of severe sepsis and septic shock
Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
Presence of at least 2 of the following conditions (These criteria should have occurred between 12 hours before or 6 hours after the onset of the qualifying first organ dysfunction)

Summary

Conditions
  • Septic Shock
  • Severe Sepsis
Type
Observational
Design
Time Perspective: Prospective

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Description

Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activit...

Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients. The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin. The critical component of the LAL reagents used in endotoxin tests is derived from blood cells (amebocytes) of the horseshoe crab, Limulus polyphemus. It contains the proteins of the blood clotting mechanism, which is triggered by endotoxins. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter 85) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (Part I, General Tests, No. 6). We will adopt the chromogenic method as purchased from the Associates of Cape Cod Inc. (ACC). The LAL reagent is formulated with a synthetic substrate which gives a yellow color when acted upon by endotoxin activated enzyme. The test is read at 405 nm, usually in a microplate reader. The severity of multiple organ dysfunction and 28-day mortality will be followed up.

Inclusion Criteria

Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
Tachycardia (heart rate > 90 bpm)
Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
...
Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
Tachycardia (heart rate > 90 bpm)
Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
ICU patients with new onset of severe sepsis and septic shock
Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
Presence of at least 2 of the following conditions (These criteria should have occurred between 12 hours before or 6 hours after the onset of the qualifying first organ dysfunction)

Locations

Taipei
Taipei

Tracking Information

NCT #
NCT01957254
Collaborators
Not Provided
Investigators
  • Principal Investigator: Yu-Chang Yeh, Ph.D. Department of Anesthesiology, National Taiwan University Hospital
  • Yu-Chang Yeh, Ph.D. Department of Anesthesiology, National Taiwan University Hospital