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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06393062
Enrollment
245
Registered
2024-05-01
Start date
2022-12-01
Completion date
2025-09-30
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Nephrolithotomy

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTGram 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.

Sponsors

Adiyaman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.immediately after the surgeryGram 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.

Secondary

MeasureTime frameDescription
Change of antibiotic regimen after bacterial estimation of Gram stainimmediately after the surgeryThe 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

Countries

Turkey (Türkiye)

Contacts

Primary ContactBedreddin Kalyenci
bedreddin84@windowslive.com+905554859583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026