Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007352
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-08-17
Brief Title:
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 oralintravenous 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 μgmL 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
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 oralintravenous 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 μgmL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |