Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia

November 25, 2020 updated by: Spectrum Health - Lakeland
Procalcitonin levels checked initially and at 24 hours will correlate with disease severity, morbidity, and mortality. Patients who have a higher procalcitonin level initially and at 24 hours will likely have higher qSOFA scores, longer lengths of stay, longer duration of antibiotics and higher 30 day mortality rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level, much like the current initial and 4 hour lactate orders are set-up. These patients will receive treatment for their pneumonia as is deemed appropriate by their care teams, both in the Emergency Department and while an inpatient. Then, after discharge, the 30 day mortality, length of stay, choice of antibiotic therapy, and qSOFA score (which will be retroactively calculated) will be compared to the patient's initial and 24 hour procalcitonin level.

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients seen at Lakeland St. Joseph and Niles Hospitals in the emergency department and who are then subsequently admitted with pneumonia at Lakeland St. Joseph and Niles Hospitals

Description

Inclusion Criteria:

  • All patients seen at Lakeland St. Joseph and Niles Hospitals in the emergency department and who are then subsequently admitted with pneumonia at Lakeland St. Joseph and Niles Hospitals

Exclusion Criteria:

  • Any patients not admitted with pneumonia, any patients who are admitted with another primary diagnosis other than pneumonia, any patients who do not have an initial or 24 hour procalcitonin level result, and any patients less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Procalcitonin lab test
A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level. These patients will receive treatment for their pneumonia as is deemed appropriate by their care teams, both in the Emergency Department and while an inpatient. Then, after discharge, the 30 day mortality, length of stay, choice of antibiotic therapy, and qSOFA score (which will be retroactively calculated) will be compared to the patient's initial and 24 hour procalcitonin level.
Diagnostic test: Procalcitonin lab test
A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Procalcitonin level
Time Frame: Measured at baseline and at 24 hours
Change in procalcitonin level in the blood serum
Measured at baseline and at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qSOFA score
Time Frame: baseline and at 24 hours
qSOFA score is based on blow blood pressure, high respiratory rate, and altered mental status
baseline and at 24 hours
Length of stay
Time Frame: an average of 30 days
Length of stay in days, total stay from admission until discharge
an average of 30 days
Duration of antibiotics
Time Frame: an average of 30 days
Antibiotic treatment length in days
an average of 30 days
30 Day Mortality
Time Frame: 30 days
Number of patients who expire vs those alive at 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health - Lakeland

Collaborators

Michigan State University

Investigators

  • Principal Investigator: Michelino Mancini, DO, Lakeland Hospitals at St. Joseph and Niles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 2, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMMC#1577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans to share IPD data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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