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TerminatedNCT01957254Updated Dec 3, 2014

Investigate the Activity of Endotoxin in Severe Sepsis

An observational study in Severe Sepsis and Septic Shock, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by National Taiwan University Hospital · Observational

Why this study was terminated
The quality of Limulus Amebocyte Lysate (LAL) test was poor.
Study type
Observational
Time perspective
Prospective
Enrollment
2
Ages
20 Years and older
Sex
All
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Study summary

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 at certain time points according to the protocol.

Read the detailed 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 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.

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Conditions studied

  • Severe Sepsis
  • Septic Shock
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 2 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with severe sepsis and septic shock

Inclusion criteria

  • ICU patients with new onset of severe sepsis and septic shock
  • 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)
  • Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
  • Tachycardia (heart rate > 90 bpm)
  • Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
  • Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)

Exclusion criteria

Exclusion Criteria:

Patient will be excluded if they

  • are under 20 years old or older than 99 years old
  • have suffered from severe sepsis or septic shock more than 24 hours
  • are pregnant
  • were treated with another medicine or device in the trial less than 30 days prior to the admission to this trial
  • have received organ transplantation less than 1 years prior to this trial
  • are terminally ill, for examples with metastasis, with a life expectancy of less than 30 days (certified by the attending physician)
  • have already received other blood cleaning treatments, such as CVVH, HD, HF, and PE upon entry into the trial
  • have chosen palliative care and signed Do Not Resuscitate sheet
  • non-native speaker
05

Study design

Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • Severe Sepsis

    Patient with severe sepsis

06

What researchers measure

Primary outcomes

  1. Endotoxin activity

    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.

    Time frame: baseline

Secondary outcomes

  1. Change of endotoxin activity

    Compare the change of endotoxin activity at different time points.

    Time frame: At enrollment, 24h, 48h, and 72h

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01957254
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Oct 8, 2013
Start date
Jan 2013
Primary completion
Jun 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Dec 3, 2014

Study contacts

Yu-Chang Yeh, Ph.D.
principal investigator · Department of Anesthesiology, National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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