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Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

Primary Purpose

Urinary Tract Infection Bacterial, Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
peripheric blood count
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection Bacterial focused on measuring fever, bacteremia, lymphocytes, percutaneous nephrolithotomy, neutrophil-lymphocyte ratio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Erciyes University Faculty of Medicine Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fever

No fever

Arm Description

patients that have fever after PNL

Patients without fever after PNL

Outcomes

Primary Outcome Measures

White blood cell count
white blood cell count
Neutrophil count
neutrophil count
N/L
ratio of neutrophil count to lymphocyte count
Lymphocyte count
Lymphocyte count

Secondary Outcome Measures

Full Information

First Posted
December 9, 2018
Last Updated
December 12, 2018
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT03774940
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
January 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection Bacterial, Nephrolithiasis
Keywords
fever, bacteremia, lymphocytes, percutaneous nephrolithotomy, neutrophil-lymphocyte ratio

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fever
Arm Type
Experimental
Arm Description
patients that have fever after PNL
Arm Title
No fever
Arm Type
Active Comparator
Arm Description
Patients without fever after PNL
Intervention Type
Diagnostic Test
Intervention Name(s)
peripheric blood count
Intervention Description
preoperative peripheric blood count
Primary Outcome Measure Information:
Title
White blood cell count
Description
white blood cell count
Time Frame
preoperative
Title
Neutrophil count
Description
neutrophil count
Time Frame
preoperative
Title
N/L
Description
ratio of neutrophil count to lymphocyte count
Time Frame
preoperative
Title
Lymphocyte count
Description
Lymphocyte count
Time Frame
preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Demirtas, MD
Organizational Affiliation
Erciyes University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University Faculty of Medicine Department of Urology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

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