Prospective Review of Procalcitonin After Cardiac Surgery

NCT ID: NCT01182688

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Brief Summary

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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

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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

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Procalcitonin Coronary Artery Bypass Grafting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampa Bay Heart Foundation

OTHER

Sponsor Role lead

Responsible Party

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Bay Area Chest Physicians, PA

Locations

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Morton Plant Hospital

Clearwater, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2008.023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2008.023

Identifier Type: -

Identifier Source: org_study_id

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