NCT01182688

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
Last Updated

August 17, 2010

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

August 16, 2010

Last Update Submit

August 16, 2010

Conditions

ProcalcitoninCoronary Artery Bypass Grafting

Keywords

utilization of Procalcitonin in the cardiac setting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Last Updated

August 17, 2010

Record last verified: 2009-10

Locations

US(1)