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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711227
• Other study ID #: MMMC#1577
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2019
• Source: Spectrum Health - Lakeland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
United States	Lakeland Regional Healthcare	Saint Joseph	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland	Michigan State University

Country where clinical trial is conducted

United States, 

References & Publications (22)

Bloos F, Marshall JC, Dellinger RP, Vincent JL, Gutierrez G, Rivers E, Balk RA, Laterre PF, Angus DC, Reinhart K, Brunkhorst FM. Multinational, observational study of procalcitonin in ICU patients with pneumonia requiring mechanical ventilation: a multicenter observational study. Crit Care. 2011;15(2):R88. doi: 10.1186/cc10087. Epub 2011 Mar 7. — View Citation

Boussekey 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. Epub 2006 Feb 14. — View Citation

Chan 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. Epub 2003 Nov 20. — View Citation

Christ-Crain M, Müller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40. — View Citation

Garnacho-Montero J, Huici-Moreno MJ, Gutiérrez-Pizarraya A, López I, Márquez-Vácaro 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. — View Citation

Hicks 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. — View Citation

Huang DT, Weissfeld LA, Kellum JA, Yealy DM, Kong L, Martino M, Angus DC; GenIMS Investigators. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia. Ann Emerg Med. 2008 Jul;52(1):48-58.e2. doi: 10.1016/j.annemergmed.2008.01.003. Epub 2008 Mar 17. — View Citation

Kim 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. — View Citation

Le 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. — View Citation

Lipinska-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. — View Citation

Liu 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. Review. — View Citation

Masiá M, Gutiérrez F, Shum C, Padilla S, Navarro JC, Flores E, Hernández 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. — View Citation

Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores during the course of sepsis and MODS. Crit Care. 1999;3(1):45-50. — View Citation

Park 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. — View Citation

Pfister 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. Review. — View Citation

Schuetz 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. Review. — View Citation

Schuetz 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. — View Citation

Schuetz 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. — View Citation

Shi 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. — View Citation

Shomali 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. — View Citation

Trásy D, Tánczos K, Németh M, Hankovszky P, Lovas A, Mikor A, László I, Hajdú E, Osztroluczki A, Fazakas J, Molnár 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. — View Citation

Wang 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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Procalcitonin level	Change in procalcitonin level in the blood serum	Measured at baseline and at 24 hours
Secondary	qSOFA score	qSOFA score is based on blow blood pressure, high respiratory rate, and altered mental status	baseline and at 24 hours
Secondary	Length of stay	Length of stay in days, total stay from admission until discharge	an average of 30 days
Secondary	Duration of antibiotics	Antibiotic treatment length in days	an average of 30 days
Secondary	30 Day Mortality	Number of patients who expire vs those alive at 30 days	30 days