Prospective Review of Procalcitonin After Cardiac Surgery

Completed

• Conditions: Procalcitonin; Coronary Artery Bypass Grafting

• Registration Number: NCT01182688
• Lead Sponsor: Tampa Bay Heart Foundation

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

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Last Update Submitted: 2010-08-16
• Study First Posted: 2010-08-17
• Last Update Posted: 2010-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States