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Urinary Tract Infection BacterialNCT03774940

Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

A study testing peripheric blood count in people with Urinary Tract Infection Bacterial and Nephrolithiasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
peripheric blood count
Could I receive a placebo?
No, everyone receives an active treatment
How many people
519 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2005to 31 Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Erciyes University Faculty of Medicine Department of Urology

    Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Neutrophil and Lymphocyte Counts and the Neutrophil-to-lymphocyte Ratio as a Predictor of Fever Following Percutaneous Nephrolithotomy in Patients Without Risk Factors

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

Read the 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.

Being tested
peripheric blood count
Keywords
fever, bacteremia, lymphocytes, percutaneous nephrolithotomy, neutrophil-lymphocyte ratio
Medical subject headings
Nephrolithiasis, Fever, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peripheric blood countDiagnostic test

    preoperative peripheric blood count

Study groups in NCT03774940
Study groupRoleWhat they receive
feverExperimentalpatients that have fever after PNL
Receives: Diagnostic Test: peripheric blood count
No feverActive comparatorPatients without fever after PNL
Receives: Diagnostic Test: peripheric blood count

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. White blood cell count

    white blood cell count

    Measured: preoperative

  2. Neutrophil count

    neutrophil count

    Measured: preoperative

  3. N/L

    ratio of neutrophil count to lymphocyte count

    Measured: preoperative

  4. Lymphocyte count

    Lymphocyte count

    Measured: preoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2018
  2. Study start1 Jan 2005
  3. Primary completion1 Dec 2013
  4. Study completion31 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
519 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03774940
Sponsor's protocol ID
2013/198
Status last verified
Dec 2018
First submitted
9 Dec 2018
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19473071

  • 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.

    PubMed 9671869

  • 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.

    PubMed 16978080

  • 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.

    PubMed 17471042

  • 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.

    PubMed 16477891

  • 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.

    PubMed 3538968

  • 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.

    PubMed 9128272

  • 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.

    PubMed 15790696

  • 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.

    PubMed 21720792

  • 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.

    PubMed 21034463

  • 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.

    PubMed 22912753

  • 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.

    PubMed 17034608

  • 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.

    PubMed 12490017

  • 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.

    PubMed 22612061

  • 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.

    PubMed 23319889

Questions about this trial

What is this clinical trial studying?

A study testing peripheric blood count in people with Urinary Tract Infection Bacterial and Nephrolithiasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

White blood cell count (time frame: preoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03774940, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.

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