Clinical trial NCT03711227: Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia
Official title: Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Serial Procalcitonin, Admitted Pneumonia, qSOFA, Sepsis
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2018-10-18
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Procalcitonin level
timeFrame: Measured at baseline and at 24 hours
Secondary outcomes:
measure: qSOFA score
timeFrame: baseline and at 24 hours
measure: Length of stay
timeFrame: an average of 30 days
measure: Duration of antibiotics
timeFrame: an average of 30 days
measure: 30 Day Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Lakeland Regional Healthcare
state: Michigan
Study officials:
affiliation: Lakeland Hospitals at St. Joseph and Niles
name: Michelino Mancini, DO
role: PRINCIPAL_INVESTIGATOR
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