Recruiting NCT05916963

Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser

Phase III Interventional Kidney Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Furosemide 40 mg.
Who it may be relevant to: Registry conditions: Kidney Stone. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

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.

Interventions

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.

Primary outcome measures

Rate of stone free patients [Time frame: At 3 months]

Secondary outcome measures (4)

Rate of urinary infection [Time frame: From baseline to 30 days]
Pain in a scale [Time frame: During the hospital stay]
Opioid consumption [Time frame: During the hospital stay, an average of 1 day]
Number of participants with adverse events [Time frame: From baseline to 3 months, an average of 1 day]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

France · 9 centers

CHU d'Angers — Angers
Hospices Civils de Lyon — Lyon
CHU de Nice — Nice
CHU de Nîmes — Nîmes
CHU de Rennes — Rennes
CHU de Rouen — Rouen
CHU de Toulouse — Toulouse
Clinique La Croix du Sud — Toulouse
… and 1 more center

Publications

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 38965611

Identifiers

NCT: NCT05916963 · 2022-502890-40-00 · DR220258

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗