NCT06007352

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.

Detailed description

The primary objective of this study is to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day post-operative symptomatic urinary tract infections in patients at higher risk of urinary tract infection undergoing stone surgery for urolithiasis. The secondary objectives of this study are to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS criteria, and overall post-operative oral/intravenous antibiotic administration. In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40 μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg. For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal function, and gentamicin peak and trough levels are not routinely obtained.

Conditions

• Urinary Tract Infections
• Sepsis

Interventions

Type	Name	Description
DRUG	Gentamicin	Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy
OTHER	Placebo	3 L of NaCl irrigation typically used for ureteroscopy surgery

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2023-08-23
• Last updated: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study