ProcalcitoninNCT01182688
Prospective Review of Procalcitonin After Cardiac Surgery
An observational study of Procalcitonin and Coronary Artery Bypass Grafting, run by Tampa Bay Heart Foundation at 1 site in United States.
Trial summary
This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procalcitonin, Coronary Artery Bypass Grafting
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2009
- 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: All patients having Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Who may be able to join
- Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Who cannot join
- Check any box that applies:
- Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass.
Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe bacterial infections and sepsis. PCT supports early diagnosis and clinical decision making.This is a prospective single center study designed to assess the normal change in PCT levels following major surgery and the utilization of PCT regarding the diagnosis of infection and the response to treatment, following major cardiac surgery
Read the detailed description
Inclusion Criteria:
Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Exclusion Criteria:
Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation
- Conditions
- Procalcitonin, Coronary Artery Bypass Grafting
- Keywords
- utilization of Procalcitonin in the cardiac setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProcalcitoninStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa Bay Heart Foundation
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182688
- Sponsor's protocol ID
- 2008.023
- Other IDs
- 2008.023
- Status last verified
- Oct 2009
- First submitted
- 16 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Review of Procalcitonin After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01182688
- Acronym / sponsor ID
- 2008.023
- Conditions
- Procalcitonin, Coronary Artery Bypass Grafting
- Keywords
- utilization of Procalcitonin in the cardiac setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tampa Bay Heart FoundationUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- First posted
- 17 Aug 2010 (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.
This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass.
Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe bacterial infections and sepsis. PCT supports early diagnosis and clinical decision making.This is a prospective single center study designed to assess the normal change in PCT levels following major surgery and the utilization of PCT regarding the diagnosis of infection and the response to treatment, following major cardiac surgery
Detailed description
Inclusion Criteria:
Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Exclusion Criteria:
Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Key inclusion criteria (1 listed)
- Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Key exclusion criteria (2 listed)
- Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation
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 17 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Procalcitonin and Coronary Artery Bypass Grafting, run by Tampa Bay Heart Foundation at 1 site in United States.
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 2 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 17 Aug 2010. 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 United States. 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 17 Aug 2010.