- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03774940
Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy
Neutrophil and Lymphocyte Counts and the Neutrophil-to-lymphocyte Ratio as a Predictor of Fever Following Percutaneous Nephrolithotomy in Patients Without Risk Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Percutaneous nephrolithotomy (PNL) is a minimally invasive treatment commonly used for renal calculi. However, the prevalence of postoperative fever is reported to be 16.7%-35%, even with appropriate prophylactic antibiotic therapy and a sterile urine culture. The most probable causes are urinary extravasation and bacteremia. Although it is important to postoperatively isolate the causative bacteria, bacterial isolation may not always be possible, and urinary and blood cultures may prove negative. In addition, establishing the etiology of fever could be time-consuming and the techniques involved may generate pseudo-negative results owing to several factors, especially the antibiotics used prophylactically. This can result in a prolonged hospital stay and increased the cost of patient care.
The most commonly used parameters for the early diagnosis of bacterial infections, despite their limited use, are C-reactive protein, white blood cell count, and neutrophil count . Superior parameters include procalcitonin, pro-adrenomedullin, interleukin (IL)-6, and IL-8, but their use is limited by their lack of availability in some centers and their higher costs. Recently, the ratio of neutrophil count to lymphocyte count (NLR) has been proposed as an effective, simple, and useful biomarker for the early diagnosis of bacterial infections. However, these tests are used after the emergence of fever. As yet, no single parameter has been proposed for predicting postoperative fever in the absence of preoperative factors known to cause fever.
The aim of this study was to investigate whether neutrophil count, lymphocyte count, and NLR obtained from routine preoperative blood tests could be used in predicting fever following PNL in patients with no risk factors for infection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kayseri, Turkey, 38039
- Erciyes University Faculty of Medicine Department of Urology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- underwent PNL operation
- preoperative white blood cell count between 4,000 and 12,000/µL
Exclusion Criteria:
- preoperative urinary system obstruction
- proliferation in preoperative and/or postoperative urine culture
- preoperative and/or postoperative blood transfusions
- a preoperative urinary diversion and/or intervention
- the presence of a postoperative residual stone
- the presence of malignancy,
- the presence of a hematologic disease.
- patients with postoperative complications graded as Clavien 2 and above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fever
patients that have fever after PNL
|
preoperative peripheric blood count
|
Active Comparator: No fever
Patients without fever after PNL
|
preoperative peripheric blood count
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
White blood cell count
Time Frame: preoperative
|
white blood cell count
|
preoperative
|
Neutrophil count
Time Frame: preoperative
|
neutrophil count
|
preoperative
|
N/L
Time Frame: preoperative
|
ratio of neutrophil count to lymphocyte count
|
preoperative
|
Lymphocyte count
Time Frame: preoperative
|
Lymphocyte count
|
preoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- de Jager CP, van Wijk PT, Mathoera RB, de Jongh-Leuvenink J, van der Poll T, Wever PC. Lymphocytopenia and neutrophil-lymphocyte count ratio predict bacteremia better than conventional infection markers in an emergency care unit. Crit Care. 2010;14(5):R192. doi: 10.1186/cc9309. Epub 2010 Oct 29.
- de Jager CP, Wever PC, Gemen EF, Kusters R, van Gageldonk-Lafeber AB, van der Poll T, Laheij RJ. The neutrophil-lymphocyte count ratio in patients with community-acquired pneumonia. PLoS One. 2012;7(10):e46561. doi: 10.1371/journal.pone.0046561. Epub 2012 Oct 1.
- Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
- Draga RO, Kok ET, Sorel MR, Bosch RJ, Lock TM. Percutaneous nephrolithotomy: factors associated with fever after the first postoperative day and systemic inflammatory response syndrome. J Endourol. 2009 Jun;23(6):921-7. doi: 10.1089/end.2009.0041.
- Cadeddu JA, Chen R, Bishoff J, Micali S, Kumar A, Moore RG, Kavoussi LR. Clinical significance of fever after percutaneous nephrolithotomy. Urology. 1998 Jul;52(1):48-50. doi: 10.1016/s0090-4295(98)00146-0.
- Sharifi Aghdas F, Akhavizadegan H, Aryanpoor A, Inanloo H, Karbakhsh M. Fever after percutaneous nephrolithotomy: contributing factors. Surg Infect (Larchmt). 2006 Aug;7(4):367-71. doi: 10.1089/sur.2006.7.367.
- Nuutila J, Lilius EM. Distinction between bacterial and viral infections. Curr Opin Infect Dis. 2007 Jun;20(3):304-10. doi: 10.1097/QCO.0b013e3280964db4.
- Lutfiyya MN, Henley E, Chang LF, Reyburn SW. Diagnosis and treatment of community-acquired pneumonia. Am Fam Physician. 2006 Feb 1;73(3):442-50.
- Shapiro MF, Greenfield S. The complete blood count and leukocyte differential count. An approach to their rational application. Ann Intern Med. 1987 Jan;106(1):65-74. doi: 10.7326/0003-4819-106-1-65.
- Seebach JD, Morant R, Ruegg R, Seifert B, Fehr J. The diagnostic value of the neutrophil left shift in predicting inflammatory and infectious disease. Am J Clin Pathol. 1997 May;107(5):582-91. doi: 10.1093/ajcp/107.5.582.
- Wyllie DH, Bowler IC, Peto TE. Bacteraemia prediction in emergency medical admissions: role of C reactive protein. J Clin Pathol. 2005 Apr;58(4):352-6. doi: 10.1136/jcp.2004.022293.
- Chalupa P, Beran O, Herwald H, Kasprikova N, Holub M. Evaluation of potential biomarkers for the discrimination of bacterial and viral infections. Infection. 2011 Oct;39(5):411-7. doi: 10.1007/s15010-011-0126-4. Epub 2011 Jul 1.
- Terradas R, Grau S, Blanch J, Riu M, Saballs P, Castells X, Horcajada JP, Knobel H. Eosinophil count and neutrophil-lymphocyte count ratio as prognostic markers in patients with bacteremia: a retrospective cohort study. PLoS One. 2012;7(8):e42860. doi: 10.1371/journal.pone.0042860. Epub 2012 Aug 9.
- Mariappan P, Smith G, Moussa SA, Tolley DA. One week of ciprofloxacin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. BJU Int. 2006 Nov;98(5):1075-9. doi: 10.1111/j.1464-410X.2006.06450.x.
- Dogan HS, Sahin A, Cetinkaya Y, Akdogan B, Ozden E, Kendi S. Antibiotic prophylaxis in percutaneous nephrolithotomy: prospective study in 81 patients. J Endourol. 2002 Nov;16(9):649-53. doi: 10.1089/089277902761402989.
- Seyrek M, Binbay M, Yuruk E, Akman T, Aslan R, Yazici O, Berberoglu Y, Muslumanoglu AY. Perioperative prophylaxis for percutaneous nephrolithotomy: randomized study concerning the drug and dosage. J Endourol. 2012 Nov;26(11):1431-6. doi: 10.1089/end.2012.0242. Epub 2012 Aug 2.
- Demirtas A, Yildirim YE, Sofikerim M, Kaya EG, Akinsal EC, Tombul ST, Ekmekcioglu O, Gulmez I. Comparison of infection and urosepsis rates of ciprofloxacin and ceftriaxone prophylaxis before percutaneous nephrolithotomy: a prospective and randomised study. ScientificWorldJournal. 2012;2012:916381. doi: 10.1100/2012/916381. Epub 2012 Dec 17.
- Goodman DA, Goodman CB, Monk JS. Use of the neutrophil:lymphocyte ratio in the diagnosis of appendicitis. Am Surg. 1995 Mar;61(3):257-9.
- Tang K, Liu H, Jiang K, Ye T, Yan L, Liu P, Xia D, Chen Z, Xu H, Ye Z. Predictive value of preoperative inflammatory response biomarkers for metabolic syndrome and post-PCNL systemic inflammatory response syndrome in patients with nephrolithiasis. Oncotarget. 2017 Aug 18;8(49):85612-85627. doi: 10.18632/oncotarget.20344. eCollection 2017 Oct 17.
- Cetinkaya M, Buldu I, Kurt O, Inan R. Platelet-to-Lymphocyte Ratio: A New Factor for Predicting Systemic Inflammatory Response Syndrome after Percutaneous Nephrolithotomy. Urol J. 2017 Aug 29;14(5):4089-4093.
- Sen V, Bozkurt IH, Aydogdu O, Yonguc T, Yarimoglu S, Sen P, Koras O, Degirmenci T. Significance of preoperative neutrophil-lymphocyte count ratio on predicting postoperative sepsis after percutaneous nephrolithotomy. Kaohsiung J Med Sci. 2016 Oct;32(10):507-513. doi: 10.1016/j.kjms.2016.08.008. Epub 2016 Sep 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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