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Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774940
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

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).

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacterial Nephrolithiasis Diagnostic Test: peripheric blood count Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 519 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : December 1, 2013
Actual Study Completion Date : January 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fever
patients that have fever after PNL
Diagnostic Test: peripheric blood count
preoperative peripheric blood count

Active Comparator: No fever
Patients without fever after PNL
Diagnostic Test: peripheric blood count
preoperative peripheric blood count




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774940


Locations
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Turkey
Erciyes University Faculty of Medicine Department of Urology
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Abdullah Demirtas, MD Erciyes University Faculty of Medicine
Publications:

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Responsible Party: Abdullah Demirtas, Assoc.Prof., TC Erciyes University
ClinicalTrials.gov Identifier: NCT03774940    
Other Study ID Numbers: 2013/198
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdullah Demirtas, TC Erciyes University:
fever
bacteremia
lymphocytes
percutaneous nephrolithotomy
neutrophil-lymphocyte ratio
Additional relevant MeSH terms:
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Urinary Tract Infections
Bacterial Infections
Nephrolithiasis
Kidney Calculi
Infection
Urologic Diseases
Kidney Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical