NCT00825357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

4.9 years

First QC Date

January 15, 2009

Last Update Submit

January 26, 2016

Conditions

Keywords

biological markerssepsisacute lung injury

Outcome Measures

Primary Outcomes (1)

  • The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage.

    72 hrs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to ICU and age ≧18-year-old.

You may qualify if:

  • Meet diagnostic criteria of ≧2 SIRS or acute lung injury.
  • Get agreement of patient's attending physician and inform consent form patient or family.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Medicine; Chi Mei Medical Center

Tainan, Taiwan

Location

MeSH Terms

Conditions

SepsisAcute Lung Injury

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 21, 2009

Study Start

September 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations