Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

Percutaneous Nephrolithotomy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393062
• Other study ID #: 2022/7-17
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Adiyaman University
• Contact: Bedreddin Kalyenci
• Phone: +905554859583
• Email: bedreddin84[@]windowslive.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Adiyaman University, Medicine of Faculty	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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