Clinical trial NCT03774940: Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection Bacterial
Nephrolithiasis
Keywords: fever
bacteremia
lymphocytes
percutaneous nephrolithotomy
neutrophil-lymphocyte ratio
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: White blood cell count
timeFrame: preoperative
measure: Neutrophil count
timeFrame: preoperative
measure: N/L
timeFrame: preoperative
measure: Lymphocyte count
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Medicine Department of Urology
Study officials:
affiliation: Erciyes University Faculty of Medicine
name: Abdullah Demirtas, MD
role: PRINCIPAL_INVESTIGATOR
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