Prospective Review of Procalcitonin After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Tampa Bay Heart Foundation
ClinicalTrials.gov Identifier:
NCT01182688
First received: August 16, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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
Procalcitonin
Coronary Artery Bypass Grafting

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prospective Review of Procalcitonin After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Tampa Bay Heart Foundation:

Enrollment: 105
Study Start Date: May 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182688

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

No publications provided

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
Study First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014