Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007352

Collaborator

(none)

412

Enrollment

Location

Arms

Anticipated Duration (Days)

418

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Sepsis	Drug: Gentamicin Other: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

412 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

phase II, parallel randomized control trial with 1:1 allocationphase II, parallel randomized control trial with 1:1 allocation

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gentamicin-Based Irrigation This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy	Drug: Gentamicin Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy
Placebo Comparator: 3 L NaCl Irrigation This group will receive the typical NaCl irrigation used during ureteroscopy	Other: Placebo 3 L of NaCl irrigation typically used for ureteroscopy surgery

Arm

Intervention/Treatment

Experimental: Gentamicin-Based Irrigation

This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy

Drug: Gentamicin

Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy

Placebo Comparator: 3 L NaCl Irrigation

This group will receive the typical NaCl irrigation used during ureteroscopy

Other: Placebo

3 L of NaCl irrigation typically used for ureteroscopy surgery

Outcome Measures

Primary Outcome Measures

Symptomatic urinary tract infection [Within 30 days of surgery]
Development of a symptomatic urinary tract infection after surgery

Secondary Outcome Measures

Urosepsis [Within 30 days of surgery]
Development of urosepsis after URS based on SIRS criteria
Re-admission to hospital [Within 30 days of surgery]
Re-admission to hospital after surgery for any reason
Patient self-reported symptoms [within 30 days of surgery]
Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis
At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below:
3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy
Prior infectious complication following ureteroscopy
Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection
Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy
Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

Estimated Glomerular Filtration Rate less than 60 mL/min
History of sensorineural hearing loss, vertigo, idiopathic dizziness
Active pregnancy or currently lactating
Known allergic reactions to components of gentamicin
Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis