SepsisNCT00229034
Effect of APC and Epo on the Inflammatory Response During Sepsis
An observational study of Sepsis and Systemic Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Systemic Inflammation
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the ICU in severe septic shock receiving either APC and/or Epo
Who may be able to join
- patients in the ICU in severe septic shock undergoing APC and/or Epo treatment
Who cannot join
- any severe comorbid conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Activated Protein C and Erythropoietin on the Microvascular Inflammatory Response During Severe Sepsis.
An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.
Read the 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.
- Conditions
- Sepsis, Systemic Inflammation
- Keywords
- Systemic Inflammation, Microvascular Perfusion, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Badhwar, PhD, Principal investigator, ScientistNeil Parry, MD, Study director, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229034
- Sponsor's protocol ID
- R-05-382
- Other IDs
- 11652E
- Status last verified
- Aug 2017
- First submitted
- 27 Sep 2005
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activated Protein C and Erythropoietin on the Microvascular Inflammatory Response During Severe Sepsis.
- ClinicalTrials.gov ID
- NCT00229034
- Acronym / sponsor ID
- R-05-382
- Conditions
- Sepsis, Systemic Inflammation
- Keywords
- Systemic Inflammation, Microvascular Perfusion, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the ICU in severe septic shock receiving either APC and/or Epo
Key inclusion criteria (1 listed)
- patients in the ICU in severe septic shock undergoing APC and/or Epo treatment
Key exclusion criteria (1 listed)
- any severe comorbid conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Badhwar, PhD principal investigator
Scientist
Neil Parry, MD study director
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Systemic Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.