Furosemide 40 mg
DrugInjection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
NCT Number: NCT05916963
In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 3
CHU d'Angers, Angers, France
Flexible ureteroscopy is the most common technique to treat kidney stones and is the treatment of choice in France.
Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created during stone destruction cannot be extracted using our surgical tools, and may stay intra-renally at the end of the procedure. Although these micro-fragments are expected to disappear spontaneously by the natural flushing and peristalsis of the upper urinary tract, they remain at risk of stagnation that could be the nest of new aggregation and stone formation.
Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy.
Nevertheless, the impact of adjuvant treatment after flexible ureteroscopy remains unclear and mainly theoretical.
In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
Loop diuretics (including Furosemide) significantly increase diuresis, which results in a greater flow of urine into the renal cavities, improving the chances of evacuating the residual fragments of the stone destroyed during flexible ureteroscopy, before they can sediment in the fundus of the renal calices or in the pyelon. Therefore, the investigators hypothesize that a forced diuresis with an injection of Furosemide at the end of ureteroscopy could improve the micro-fragments and stones dust clearance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
Time frame: At 3 months
Rate of stone-free patients 3 months after a flexible ureteroscopy for renal stone laser destruction, evaluated on the low dose abdomino-pelvic CT-Scan.
A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results
Time frame: From baseline to 30 days
Rate of post-operative urinary tract infection will be assessed within 30 days after surgery on the combination of:
Time frame: During the hospital stay
Post-operative pain will be assessed on numerical pain scale in the recovery room, in the service and at the discharge. Pain scale is from 0 (no pain) to 10 (as bad as it could be nothing else matters)
Time frame: During the hospital stay, an average of 1 day
The use of opioids will be reported
Time frame: From baseline to 3 months, an average of 1 day
Number of participants with Furosemide adverse events
Contact information is provided by the study sponsor or research team.
University Hospital, Tours
Other
FIRESTONES : Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser: a Randomized Controlled Two-parallel Group Multicenter Trial With Blinding Evaluation
Acronym: FIREStones
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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