Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

NCT06393062 | Recruiting

• 1 other identifier: 2022/7-17
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Percutaneous Nephrolithotomy

Keywords

fever; gram stain; percutaneous nephrolithotomy; Systemic inflammatory response syndrome (SIRS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of antibiotic regimen after bacterial estimation of Gram stain

  immediately after the surgery

Study Arms (2)

Gram staining

EXPERIMENTAL

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.

control

NO INTERVENTION

non-intervention percutaneous nephrolithotomy

Interventions

Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University, Medicine of Faculty

Adıyaman, 02400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fever; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes; Shock

Central Study Contacts

Bedreddin Kalyenci

CONTACT

+905554859583; bedreddin84@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor doctor

Model Details: The patients included in the study were randomized by a block randomization method by an independent researcher, hidden from the patients and the responsible clinicians, using a computerized number tool.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: December 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Data will be shared with all researchers conducting research on the prevention and detection of infectious consequences after percutaneous nephrolithotomy.

Locations

TU (1)