NCT00229034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

September 27, 2005

Last Update Submit

August 24, 2017

Conditions

SepsisSystemic Inflammation

Keywords

Systemic InflammationMicrovascular PerfusionSeptic Shock

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • any severe comorbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Amit Badhwar, PhD

    Scientist

    PRINCIPAL INVESTIGATOR

  • Neil Parry, MD

    Surgeon

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2010

Study Completion

September 1, 2011

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

CA(1)