Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdiyaman University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

245 Participants
are divided into 2 treatment groups
Group A: Gram stainingExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

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.

Time frame
immediately after the surgery

Secondary outcomes

1

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

Time frame
immediately after the surgery

Other outcomes

Sponsors and contacts

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