Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia
1 other identifier
observational
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2018
CompletedStudy Start
First participant enrolled
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedNovember 29, 2024
October 1, 2019
1 year
June 2, 2018
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Procalcitonin level
Change in procalcitonin level in the blood serum
Measured at baseline and at 24 hours
Secondary Outcomes (4)
qSOFA score
baseline and at 24 hours
Length of stay
an average of 30 days
Duration of antibiotics
an average of 30 days
30 Day Mortality
30 days
Study Arms (1)
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.
Interventions
A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level.
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corewell Health Southlead
- Michigan State Universitycollaborator
Study Sites (1)
Lakeland Regional Healthcare
Saint Joseph, Michigan, 49085, United States
Related Publications (22)
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PMID: 21385367BACKGROUNDBoussekey N, Leroy O, Alfandari S, Devos P, Georges H, Guery B. Procalcitonin kinetics in the prognosis of severe community-acquired pneumonia. Intensive Care Med. 2006 Mar;32(3):469-72. doi: 10.1007/s00134-005-0047-8. Epub 2006 Feb 14.
PMID: 16477418BACKGROUNDChan YL, Tseng CP, Tsay PK, Chang SS, Chiu TF, Chen JC. Procalcitonin as a marker of bacterial infection in the emergency department: an observational study. Crit Care. 2004 Feb;8(1):R12-20. doi: 10.1186/cc2396. Epub 2003 Nov 20.
PMID: 14975050BACKGROUNDChrist-Crain M, Muller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40. doi: 10.1007/s11908-007-0037-9.
PMID: 17430706BACKGROUNDGarnacho-Montero J, Huici-Moreno MJ, Gutierrez-Pizarraya A, Lopez I, Marquez-Vacaro JA, Macher H, Guerrero JM, Puppo-Moreno A. Prognostic and diagnostic value of eosinopenia, C-reactive protein, procalcitonin, and circulating cell-free DNA in critically ill patients admitted with suspicion of sepsis. Crit Care. 2014 Jun 5;18(3):R116. doi: 10.1186/cc13908.
PMID: 24903083BACKGROUNDHicks CW, Engineer RS, Benoit JL, Dasarathy S, Christenson RH, Peacock WF. Procalcitonin as a biomarker for early sepsis in the emergency department. Eur J Emerg Med. 2014 Apr;21(2):112-7. doi: 10.1097/MEJ.0b013e328361fee2.
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PMID: 18342993BACKGROUNDKim SY, Jeong TD, Lee W, Chun S, Min WK. Procalcitonin in the assessment of bacteraemia in emergency department patients: results of a large retrospective study. Ann Clin Biochem. 2015 Nov;52(Pt 6):654-9. doi: 10.1177/0004563214568685. Epub 2015 Jan 9.
PMID: 25575698BACKGROUNDLe Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.
PMID: 26472401BACKGROUNDLipinska-Gediga M, Mierzchala-Pasierb M, Durek G. Procalcitonin kinetics - prognostic and diagnostic significance in septic patients. Arch Med Sci. 2016 Feb 1;12(1):112-9. doi: 10.5114/aoms.2016.57587. Epub 2016 Feb 2.
PMID: 26925126BACKGROUNDLiu D, Su LX, Guan W, Xiao K, Xie LX. Prognostic value of procalcitonin in pneumonia: A systematic review and meta-analysis. Respirology. 2016 Feb;21(2):280-8. doi: 10.1111/resp.12704. Epub 2015 Dec 10.
PMID: 26662169BACKGROUNDMasia M, Gutierrez F, Shum C, Padilla S, Navarro JC, Flores E, Hernandez I. Usefulness of procalcitonin levels in community-acquired pneumonia according to the patients outcome research team pneumonia severity index. Chest. 2005 Oct;128(4):2223-9. doi: 10.1378/chest.128.4.2223.
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PMID: 11056723BACKGROUNDPark JH, Wee JH, Choi SP, Oh SH. The value of procalcitonin level in community-acquired pneumonia in the ED. Am J Emerg Med. 2012 Sep;30(7):1248-54. doi: 10.1016/j.ajem.2011.08.009. Epub 2011 Oct 24.
PMID: 22030193BACKGROUNDPfister R, Kochanek M, Leygeber T, Brun-Buisson C, Cuquemelle E, Machado MB, Piacentini E, Hammond NE, Ingram PR, Michels G. Procalcitonin for diagnosis of bacterial pneumonia in critically ill patients during 2009 H1N1 influenza pandemic: a prospective cohort study, systematic review and individual patient data meta-analysis. Crit Care. 2014 Mar 10;18(2):R44. doi: 10.1186/cc13760.
PMID: 24612487BACKGROUNDSchuetz P, Amin DN, Greenwald JL. Role of procalcitonin in managing adult patients with respiratory tract infections. Chest. 2012 Apr;141(4):1063-1073. doi: 10.1378/chest.11-2430.
PMID: 22474148BACKGROUNDSchuetz P, Birkhahn R, Sherwin R, Jones AE, Singer A, Kline JA, Runyon MS, Self WH, Courtney DM, Nowak RM, Gaieski DF, Ebmeyer S, Johannes S, Wiemer JC, Schwabe A, Shapiro NI. Serial Procalcitonin Predicts Mortality in Severe Sepsis Patients: Results From the Multicenter Procalcitonin MOnitoring SEpsis (MOSES) Study. Crit Care Med. 2017 May;45(5):781-789. doi: 10.1097/CCM.0000000000002321.
PMID: 28257335BACKGROUNDSchuetz P, Maurer P, Punjabi V, Desai A, Amin DN, Gluck E. Procalcitonin decrease over 72 hours in US critical care units predicts fatal outcome in sepsis patients. Crit Care. 2013 Jun 20;17(3):R115. doi: 10.1186/cc12787.
PMID: 23787145BACKGROUNDShi Y, Peng JM, Hu XY, Wang Y. The utility of initial procalcitonin and procalcitonin clearance for prediction of bacterial infection and outcome in critically ill patients with autoimmune diseases: a prospective observational study. BMC Anesthesiol. 2015 Oct 7;15:137. doi: 10.1186/s12871-015-0122-9.
PMID: 26446077BACKGROUNDShomali W, Hachem R, Chaftari AM, Jiang Y, Bahu R, Jabbour J, Raad S, Al Shuaibi M, Al Wohoush I, Raad I. Can procalcitonin distinguish infectious fever from tumor-related fever in non-neutropenic cancer patients? Cancer. 2012 Dec 1;118(23):5823-9. doi: 10.1002/cncr.27602. Epub 2012 May 17.
PMID: 22605389BACKGROUNDTrasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Laszlo I, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A prospective observational study. J Crit Care. 2016 Aug;34:50-5. doi: 10.1016/j.jcrc.2016.04.007. Epub 2016 Apr 13.
PMID: 27288610BACKGROUNDWang XJ, Tan TT, Lim ST, Farid M, Tao M, Quek R, Chan A, Tang T. Role of Procalcitonin in Differentiating between Infectious and Noninfectious Fevers among Patients with Lymphoma. Pharmacotherapy. 2017 Aug;37(8):908-915. doi: 10.1002/phar.1963. Epub 2017 Jul 18.
PMID: 28556122BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelino Mancini, DO
Lakeland Hospitals at St. Joseph and Niles
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2018
First Posted
October 18, 2018
Study Start
July 17, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
November 29, 2024
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
No plans to share IPD data