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Trial record 40 of 5988 for:    zero

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

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ClinicalTrials.gov Identifier: NCT03711227
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
Lakeland Health

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.

Condition or disease Intervention/treatment
Pneumonia Diagnostic Test: Procalcitonin lab test

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.




Primary Outcome Measures :
  1. Change in Procalcitonin level [ Time Frame: Measured at baseline and at 24 hours ]
    Change in procalcitonin level in the blood serum


Secondary Outcome Measures :
  1. qSOFA score [ Time Frame: baseline and at 24 hours ]
    qSOFA score is based on blow blood pressure, high respiratory rate, and altered mental status

  2. Length of stay [ Time Frame: an average of 30 days ]
    Length of stay in days, total stay from admission until discharge

  3. Duration of antibiotics [ Time Frame: an average of 30 days ]
    Antibiotic treatment length in days

  4. 30 Day Mortality [ Time Frame: 30 days ]
    Number of patients who expire vs those alive at 30 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711227


Contacts
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Contact: Tomasz Przednowek, DO 269-983-8300 tprzednowek1@lakelandhealth.org
Contact: Tiffany Proffitt, DO 269-98308300 tproffitt1@lakelandhealth.org

Locations
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United States, Michigan
Lakeland Regional Healthcare Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michelino Mancini, DO, FAOECP    269-983-4081    mmancini@lakelandhealth.org   
Sponsors and Collaborators
Lakeland Health
Michigan State University
Investigators
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Principal Investigator: Michelino Mancini, DO Lakeland Hospitals at St. Joseph and Niles

Publications:

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Responsible Party: Lakeland Health
ClinicalTrials.gov Identifier: NCT03711227     History of Changes
Other Study ID Numbers: MMMC#1577
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lakeland Health:
Serial Procalcitonin, Admitted Pneumonia, qSOFA, Sepsis

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections