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
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
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
NCT ID
NCT03774940
First Posted
December 9, 2018
Last Updated
December 12, 2018
Sponsor
TC Erciyes University
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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