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Prospective Review of Procalcitonin After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01182688
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

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


Condition or disease
Procalcitonin Coronary Artery Bypass Grafting

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

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prospective Review of Procalcitonin After Cardiac Surgery
Study Start Date : May 2009
Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients having Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases
Criteria

Inclusion Criteria:

Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Exclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182688


Locations
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Sponsors and Collaborators
Tampa Bay Heart Foundation
More Information

Responsible Party: Devednra Amin, MD, Bay Area Chest Physicians, PA
ClinicalTrials.gov Identifier: NCT01182688     History of Changes
Other Study ID Numbers: 2008.023
2008.023 ( Other Grant/Funding Number: TampaBay Heart Foundation )
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: October 2009

Keywords provided by Tampa Bay Heart Foundation:
utilization of Procalcitonin in the cardiac setting

Additional relevant MeSH terms:
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs