Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03774940
Other study ID # 2013/198
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2005
Est. completion date January 31, 2014

Study information

Verified date December 2018
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 519
Est. completion date January 31, 2014
Est. primary completion date December 1, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
peripheric blood count
preoperative peripheric blood count

Locations

Country Name City State
Turkey Erciyes University Faculty of Medicine Department of Urology Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

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. — View Citation

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. — View Citation

Chalupa P, Beran O, Herwald H, Kaspríková 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nuutila J, Lilius EM. Distinction between bacterial and viral infections. Curr Opin Infect Dis. 2007 Jun;20(3):304-10. Review. — View Citation

Seebach JD, Morant R, Rüegg 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary White blood cell count white blood cell count preoperative
Primary Neutrophil count neutrophil count preoperative
Primary N/L ratio of neutrophil count to lymphocyte count preoperative
Primary Lymphocyte count Lymphocyte count preoperative
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT03692715 - Antibiotic Prophylaxis Before Shock Wave Lithotripsy Phase 4
Completed NCT02547805 - Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days Phase 2
Completed NCT02289755 - Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria Phase 2
Completed NCT01690039 - Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
Completed NCT01650935 - Comparison of DASH With Oxalate Restricted Diet on Urine in Recurrent Stone Formers With Hyperoxaluria N/A
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Recruiting NCT05014178 - Kidney Sodium Functional Imaging
Not yet recruiting NCT06199102 - The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. N/A
Recruiting NCT04367155 - Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. N/A
Recruiting NCT04374188 - Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Recruiting NCT04389853 - Mini-PNCL vs fURS in Management of Nephrolithiasis N/A
Completed NCT03348228 - Effect of Hydroxycitrate on Urine Chemistry N/A
Completed NCT05350423 - Trial Assessing Renal Damage During Ureteroscopy N/A
Completed NCT03454139 - Subcostal TAP Block For Percutaneous Nephrolithotomy N/A
Recruiting NCT02279927 - Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy N/A
Completed NCT02276924 - Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors N/A
Completed NCT00159393 - Percutaneous Nephrolithotomy: A Registry and Database