Investigate the Activity of Endotoxin in Severe Sepsis

NCT01957254 | Terminated

• 1 other identifier: 201211040RIB
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Sepsis; Septic Shock

Outcome Measures

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.

  baseline

Secondary Outcomes (1)

• Change of endotoxin activity

  At enrollment, 24h, 48h, and 72h

Study Arms (1)

Severe Sepsis

Patient with severe sepsis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe sepsis and septic shock

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Yu-Chang Yeh, Ph.D.

  Department of Anesthesiology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: October 8, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

TW (1)