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Completed

NCT Number: NCT03774940

Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peripheric blood count

Diagnostic Test

preoperative peripheric blood count

Primary outcomes

  1. White blood cell count

    Time frame: preoperative

    white blood cell count

  2. Neutrophil count

    Time frame: preoperative

    neutrophil count

  3. N/L

    Time frame: preoperative

    ratio of neutrophil count to lymphocyte count

  4. Lymphocyte count

    Time frame: preoperative

    Lymphocyte count

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Dec 13, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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