Effect of APC and Epo on the Inflammatory Response During Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00229034
First received: September 27, 2005
Last updated: December 19, 2008
Last verified: December 2008
  Purpose

An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.


Condition
Sepsis
Systemic Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Activated Protein C and Erythropoietin on the Microvascular Inflammatory Response During Severe Sepsis.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis. Patients already prescribed either drug will be enrolled. The microcirculation of the sublingual vascular bed will be observed with a microscope to detect the alterations in the inflammatory response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the ICU in severe septic shock receiving either APC and/or Epo

Criteria

Inclusion Criteria:

  • patients in the ICU in severe septic shock undergoing APC and/or Epo treatment

Exclusion Criteria:

  • any severe comorbid conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229034

Contacts
Contact: Amit Badhwar, PhD 519.685.8500 amit.badhwar@uwo.ca

Locations
Canada, Ontario
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Amit Badhwar, PhD    519.685.8500    amit.badhwar@uwo.ca   
Principal Investigator: Amit Badhwar, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Amit Badhwar, PhD Scientist
Study Director: Neil Parry, MD Surgeon
  More Information

No publications provided

Responsible Party: Dr. N. Badhwar, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00229034     History of Changes
Other Study ID Numbers: R-05-382, 11652E
Study First Received: September 27, 2005
Last Updated: December 19, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Systemic Inflammation
Microvascular Perfusion
Septic Shock

Additional relevant MeSH terms:
Inflammation
Sepsis
Toxemia
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on September 18, 2014