FIRE Stones: 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
Study Details
Study Description
Brief Summary
In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, we chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Furosemide Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. |
Drug: Furosemide 40 mg
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
|
| No Intervention: Usual care Usual care, without injection of Furosemide. |
Outcome Measures
Primary Outcome Measures
- Stone free rate [At 3 months]
Stone-free rate at 3 months of 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
Secondary Outcome Measures
- Urinary infection [From baseline to 30 days]
Post-operative urinary tract infection will be assessed within 30 days after surgery on the combination of: Fever higher than 38.5°C and/or, Chills and/or, Clinical symptoms (supra-pubic pain, dysuria, pollakiuria, urgency, urinary burning, back pain radiating to the genitals, hematuria) and/or Positive urine culture with a significant bacteriuria threshold defined as bacteriuria ≥10^5 UFC/mL with one or two bacterial species.
- Pain in a scale [On the day of the surgery]
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)
- Adverse events [From baseline to 3 months]
Furosemide adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients ≥ 18 years old
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With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
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Participants covered by or entitled to social security
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Written informed consent obtained from the participant
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Ability for participant to comply with the requirements of the study
Exclusion Criteria:
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Patients following any measures of legal presentation
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Contra-indication to Furosemide:
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Hyper-sensitivity to the active substance or one of the excipients
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Hyper-sensitivity to Sulfonamide
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Renal failure with oligo-anuria refractory to Furosemide
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Hypokalemia < 3,5 mmol/L
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Severe hyponatremia
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Hypovolemia with or without hypotension or dehydration
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Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
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Patient having Furosemide as usual treatment
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Pregnancy, breastfeeding
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Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
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Participation in other interventional research with an investigational drug or medical device
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Tours
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-502890-40-00