NCT03774940

Brief Summary

To investigate the relationship between neutrophil count, lymphocyte count, neutrophil-to-lymphocyte count ratio (NLR), and postoperative fever in patients undergoing percutaneous nephrolithotomy (PNL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

8.9 years

First QC Date

December 9, 2018

Last Update Submit

December 12, 2018

Conditions

Keywords

feverbacteremialymphocytespercutaneous nephrolithotomyneutrophil-lymphocyte ratio

Outcome Measures

Primary Outcomes (4)

  • White blood cell count

    white blood cell count

    preoperative

  • Neutrophil count

    neutrophil count

    preoperative

  • N/L

    ratio of neutrophil count to lymphocyte count

    preoperative

  • Lymphocyte count

    Lymphocyte count

    preoperative

Study Arms (2)

fever

EXPERIMENTAL

patients that have fever after PNL

Diagnostic Test: peripheric blood count

No fever

ACTIVE COMPARATOR

Patients without fever after PNL

Diagnostic Test: peripheric blood count

Interventions

peripheric blood countDIAGNOSTIC_TEST

preoperative peripheric blood count

No feverfever

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • underwent PNL operation
  • preoperative white blood cell count between 4,000 and 12,000/µL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Medicine Department of Urology

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (21)

  • 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.

    PMID: 19473071BACKGROUND
  • 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.

    PMID: 9671869BACKGROUND
  • 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.

    PMID: 16978080BACKGROUND
  • 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.

    PMID: 17471042BACKGROUND
  • 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.

    PMID: 16477891BACKGROUND
  • 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.

    PMID: 3538968BACKGROUND
  • 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.

    PMID: 9128272BACKGROUND
  • 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.

    PMID: 15790696BACKGROUND
  • 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.

    PMID: 21720792BACKGROUND
  • 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.

    PMID: 21034463BACKGROUND
  • 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.

    PMID: 22912753BACKGROUND
  • 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.

    PMID: 17034608BACKGROUND
  • 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.

    PMID: 12490017BACKGROUND
  • 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.

    PMID: 22612061BACKGROUND
  • 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.

    PMID: 23319889BACKGROUND
  • 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.

    PMID: 11723675BACKGROUND
  • 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.

    PMID: 7887542BACKGROUND
  • 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.

    PMID: 23049706BACKGROUND
  • 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.

    PMID: 29156745BACKGROUND
  • 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.

    PMID: 28853103BACKGROUND
  • 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.

    PMID: 27742034BACKGROUND

MeSH Terms

Conditions

NephrolithiasisFeverBacteremia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Officials

  • Abdullah Demirtas, MD

    Erciyes University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 13, 2018

Study Start

January 1, 2005

Primary Completion

December 1, 2013

Study Completion

January 31, 2014

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations