Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser
FIREStones
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
2 other identifiers
interventional
374
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2024
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
January 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2026
CompletedNovember 24, 2025
November 1, 2025
2.2 years
June 14, 2023
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of stone free patients
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
At 3 months
Secondary Outcomes (4)
Rate of urinary infection
From baseline to 30 days
Pain in a scale
During the hospital stay
Opioid consumption
During the hospital stay, an average of 1 day
Number of participants with adverse events
From baseline to 3 months, an average of 1 day
Study Arms (2)
Furosemide
EXPERIMENTALInjection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
Usual care
NO INTERVENTIONUsual care, without injection of Furosemide.
Interventions
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years old and \< 80 years old
- With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
- Participants covered by or entitled to social security
- Written informed consent obtained from the participant
- Ability for participant to comply with the requirements of the study
You may not qualify if:
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)
- Contra-indication to Furosemide:
- Hyper-sensitivity to the active substance or one of the excipients
- Hyper-sensitivity to Sulfonamide
- Renal failure with oligo-anuria refractory to Furosemide
- Hypokalemia \< 3,5 mmol/L
- Severe hyponatremia
- Hypovolemia with or without hypotension or dehydration
- Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
- Patient having Furosemide as usual treatment
- Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
- Participation in other interventional research with an investigational drug or medical device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
CHU d'Angers
Angers, France
Hospices Civils de Lyon
Lyon, France
CHU de Nice
Nice, France
CHU de Nîmes
Nîmes, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
CHU de Toulouse
Toulouse, France
Clinique La Croix du Sud
Toulouse, France
CHRU de Tours
Tours, France
Related Publications (1)
Letouche ML, Giraudeau B, Agier MS, Bruyere F. FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser-protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation. Trials. 2024 Jul 4;25(1):455. doi: 10.1186/s13063-024-08309-0.
PMID: 38965611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study will not be blinded except for the outcome assessment: radiologists in charge of interpreting CT-Scans will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2023
First Posted
June 23, 2023
Study Start
January 4, 2024
Primary Completion
April 3, 2026
Study Completion
April 3, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share