Biological Markers to Identify Early Sepsis and Acute Lung Injury

Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825357
• Other study ID #: CM-IRB09509002
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: January 26, 2016
• Start date: September 2006
• Est. completion date: August 2011

Study information

• Verified date: January 2016
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

There are no clear markers to identify sepsis and acute lung injury at early stage in clinical settings which would result in improved survival of the patients. In collaboration with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular diseases in ICU patients. These findings may provide valuable information for therapeutic guideline in clinical practice. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury. We will examine the roles of three components of markers including inflammation, neutrophil activation and coagulation. We are hoping that this proposed translational research will help develop novel therapeutic strategy in sepsis and acute lung injury patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet diagnostic criteria of ?2 SIRS or acute lung injury.

• Get agreement of patient's attending physician and inform consent form patient or family.

Exclusion Criteria:

• Use Antibiotics over 24 hrs(only SIRS group).

• Active bleeding.

• Pregnancy.

• Active Cancer (refer to malignancy which is recently diagnosed, under treatment, or relapsed)

• VS or Subject or Family refuse

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Sepsis

Locations

Country	Name	City	State
Taiwan	Department of Intensive Care Medicine; Chi Mei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage.		72 hrs	No