Blood Parameters as a Predictor of Fever After Percutaneous Nephrolithotomy

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT03774940
Collaborator
(none)
519
1
2
109
4.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: peripheric blood count
N/A

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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2005
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Jan 31, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. White blood cell count [preoperative]

    white blood cell count

  2. Neutrophil count [preoperative]

    neutrophil count

  3. N/L [preoperative]

    ratio of neutrophil count to lymphocyte count

  4. Lymphocyte count [preoperative]

    Lymphocyte count

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erciyes University Faculty of Medicine Department of Urology Kayseri Turkey 38039

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Principal Investigator: Abdullah Demirtas, MD, Erciyes University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdullah Demirtas, Assoc.Prof., TC Erciyes University
ClinicalTrials.gov Identifier:
NCT03774940
Other Study ID Numbers:
  • 2013/198
First Posted:
Dec 13, 2018
Last Update Posted:
Dec 13, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdullah Demirtas, Assoc.Prof., TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2018