Nephrolithiasis Clinical Trial
Official title:
A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Ureteroscopy in Moderate to High Infectious Risk Population
The goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. The main questions it aims to answer are: 1. Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days) 2. Identify secondary predictors of post-operative infectious complications
Post-operative infectious complications including urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), and sepsis are uncommon but potentially devastating complications after ureteroscopy. The clinical guidance from the American Urologic Association (AUA) and the European Association of Urology (EAU) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. As a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. This is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (MDR) organisms but are also more susceptible to deleterious outcomes due to their frailty. Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (PCNL) for stone removal. Ureteroscopy is the most commonly performed stone surgery worldwide. Establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. The goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04746378 -
PRedictive Accuracy of Initial Stone Burden Evaluation.
|
||
Recruiting |
NCT05100017 -
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
|
N/A | |
Recruiting |
NCT03692715 -
Antibiotic Prophylaxis Before Shock Wave Lithotripsy
|
Phase 4 | |
Completed |
NCT02547805 -
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
|
Phase 2 | |
Completed |
NCT02289755 -
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
|
Phase 2 | |
Completed |
NCT01690039 -
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
|
||
Completed |
NCT01650935 -
Comparison of DASH With Oxalate Restricted Diet on Urine in Recurrent Stone Formers With Hyperoxaluria
|
N/A | |
Completed |
NCT01295879 -
Vitamin D Repletion in Stone Formers With Hypercalciuria
|
Phase 4 | |
Recruiting |
NCT05014178 -
Kidney Sodium Functional Imaging
|
||
Not yet recruiting |
NCT06199102 -
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
|
N/A | |
Recruiting |
NCT04367155 -
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
|
N/A | |
Recruiting |
NCT04374188 -
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy
|
N/A | |
Recruiting |
NCT05701098 -
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
|
N/A | |
Recruiting |
NCT04389853 -
Mini-PNCL vs fURS in Management of Nephrolithiasis
|
N/A | |
Completed |
NCT03348228 -
Effect of Hydroxycitrate on Urine Chemistry
|
N/A | |
Completed |
NCT05350423 -
Trial Assessing Renal Damage During Ureteroscopy
|
N/A | |
Completed |
NCT03454139 -
Subcostal TAP Block For Percutaneous Nephrolithotomy
|
N/A | |
Recruiting |
NCT02279927 -
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy
|
N/A | |
Completed |
NCT02276924 -
Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
|
N/A | |
Completed |
NCT00159393 -
Percutaneous Nephrolithotomy: A Registry and Database
|