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NCT Number: NCT06393062

Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Percutaneous Nephrolithotomy Body Temperature Changes Fever Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adıyaman University, Medicine of Faculty

Adıyaman, 02400, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bedreddin Kalyenci, MD

CONTACT

[email protected]

+905554859583

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.

    Time frame: immediately after the surgery

    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.

Secondary outcomes

  1. Change of antibiotic regimen after bacterial estimation of Gram stain

    Time frame: immediately after the surgery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Bedreddin Kalyenci

CONTACT

[email protected]

+905554859583

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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