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NCT01182688 Clinical Trial

Prospective Review of Procalcitonin After Cardiac Surgery

Coronary Artery Bypass Grafting Clinical Trial

Official title:
Prospective Review of Procalcitonin After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01182688
Other study ID # 2008.023
Secondary ID 2008.023
Status Completed
Phase N/A
First received August 16, 2010
Last updated August 16, 2010
Start date May 2009

Study information
Verified date October 2009
Source Tampa Bay Heart Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.

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

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

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Morton Plant Hospital Clearwater Florida

Sponsors (1)
Lead Sponsor Collaborator
Tampa Bay Heart Foundation

Country where clinical trial is conducted

United States, 

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