Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study

In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Diagnostic test: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.

• Study Type: Interventional
• Enrollment (Estimated): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bedreddin Kalyenci; Phone Number: +905554859583; Email: bedreddin84@windowslive.com

Study Locations

• Turkey
  • Adıyaman, Turkey, 02400
    • Recruiting
    • Adıyaman University, Medicine of Faculty
    • Contact: Bedreddin Kalyenci, MD; Phone Number: +905554859583; Email: bedreddin84@windowslive.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.

Exclusion Criteria:

• under 18 years old,
• having an active urinary tract infection before surgery and positive urine cultures,
• Patients with bilateral kidney stones,
• DJ stent or nephrostomy placement,
• Solitary kidney stones,
• Bleeding disorders,
• impaired kidney function,
• a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gram staining; Gram staining of post-puncture urine in percutaneous nephrolithotomy	Diagnostic test: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.; Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
No Intervention: control; non-intervention percutaneous nephrolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.	Gram staining of urine after puncture to detect the presence of bacteria that are a possible source of infection according to the rate of gram-stained and non-gram-stained patients by microscopic examination.	immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of antibiotic regimen after bacterial estimation of Gram stain	The percentage of patients whose antibiotic regimen was changed by estimating bacteria after Gram staining did not progress to systemic inflammatory response syndrome. Systemic inflammatory response criteria: temperature less than 36 °C or higher than 38 °C, heart rate more than 100 beats per minute, respiratory rate more than 20 per minute, leukocyte count greater than 12 × 10 up 9/L or 4 × 10 up 9/L less than L, systolic blood pressure falling below 90 mmHg, or diastolic blood pressure falling below 40 mmHg	immediately after the surgery

Collaborators and Investigators

• Sponsor: Adiyaman University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: fever; percutaneous nephrolithotomy; gram stain; Systemic inflammatory response syndrome (SIRS)
• Other Study ID Numbers: 2022/7-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient clinical data before and after surgery
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Data will be shared with all researchers conducting research on the prevention and detection of infectious consequences after percutaneous nephrolithotomy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No