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Prospective Review of Procalcitonin After Cardiac Surgery

Sponsor
Tampa Bay Heart Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01182688
Collaborator
(none)
105
Enrollment
1
Location

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    105 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Prospective Review of Procalcitonin After Cardiac Surgery
    Study Start Date :
    May 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Morton Plant Hospital Clearwater Florida United States 33756

      Sponsors and Collaborators

      • Tampa Bay Heart Foundation

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01182688
      Other Study ID Numbers:
      • 2008.023
      • 2008.023
      First Posted:
      Aug 17, 2010
      Last Update Posted:
      Aug 17, 2010
      Last Verified:
      Oct 1, 2009
      Keywords provided by , ,
      utilization of Procalcitonin in the cardiac setting

      Study Results

      No Results Posted as of Aug 17, 2010