Prospective Review of Procalcitonin After Cardiac Surgery - Full Text View

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:

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Surgery

U.S. FDA Resources

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:

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 October 17, 2012