Påvirkning av tvungen diurese på gjenværende fragmenteringsfrekvens etter fleksibel ureteroskopi for ødeleggelse av nyrestein med laser: en randomisert kontrollert to-parallell gruppe multisenterforsøk med blindevaluering (FIREStones)
BRANDSTEINER: Påvirkning av tvungen diurese på gjenværende fragmenteringsfrekvens etter fleksibel ureteroskopi for ødeleggelse av nyrestein med laser: en randomisert kontrollert to-parallell gruppe multisenterforsøk med blindevaluering
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Marie-Lou LETOUCHE, MD
- Telefonnummer: +33247474665
- E-post: marielou.letouche@gmail.com
Studiesteder
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Angers, Frankrike
- Rekruttering
- CHU d'Angers
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Ta kontakt med:
- Pierre BIGOT
- Telefonnummer: +332 41 35 64 94
- E-post: pibigot@chu-angers.fr
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Hovedetterforsker:
- Pierre BIGOT
-
Lyon, Frankrike
- Rekruttering
- Hospices Civils de Lyon
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Ta kontakt med:
- Nadia ABID
- Telefonnummer: +33472119675
- E-post: nadia.abid@chu-lyon.fr
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Hovedetterforsker:
- Nadia ABID
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Nice, Frankrike
- Rekruttering
- CHU de Nice
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Ta kontakt med:
- Mathieu DURAND
- Telefonnummer: +33492031637
- E-post: durand.m@chu-nice.fr
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Hovedetterforsker:
- Mathieu DURAND
-
Nîmes, Frankrike
- Rekruttering
- CHU de Nîmes
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Ta kontakt med:
- Stéphane DROUPY
- Telefonnummer: +334 66 68 33 53
- E-post: stephane.droupy@chu-nimes.fr
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Hovedetterforsker:
- Stéphane DROUPY
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Rennes, Frankrike
- Rekruttering
- CHU de Rennes
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Ta kontakt med:
- Karim BENSALAH
- Telefonnummer: +332 99 28 42 70
- E-post: charles-karim.BENSALAH@chu-rennes.fr
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Hovedetterforsker:
- Karim BENSALAH
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Rouen, Frankrike
- Rekruttering
- CHU de Rouen
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Ta kontakt med:
- Hugo DUPUIS
- Telefonnummer: +332 32 88 89 90
- E-post: hugo.dupuis@chu-rouen.fr
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Hovedetterforsker:
- Hugo DUPUIS
-
Toulouse, Frankrike
- Rekruttering
- CHU de Toulouse
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Hovedetterforsker:
- Xavier GAME
-
Ta kontakt med:
- Xavier GAME
- Telefonnummer: +33561323106
- E-post: game.x@chu-toulouse.fr
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Toulouse, Frankrike
- Rekruttering
- Clinique La Croix du Sud
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Ta kontakt med:
- Christophe ALMERAS
- Telefonnummer: +335 32 02 72 02
- E-post: c.almeras@gmail.com
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Hovedetterforsker:
- Christophe ALMERAS
-
Tours, Frankrike
- Rekruttering
- CHRU de Tours
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Ta kontakt med:
- Marie-Lou LETOUCHE
- Telefonnummer: +336 74 75 71 13
- E-post: marielou.letouche@gmail.com
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Hovedetterforsker:
- Marie-Lou LETOUCHE
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
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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)
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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
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Patient having Furosemide as usual treatment
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Furosemide
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. |
Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser. |
|
Ingen inngripen: Usual care
Usual care, without injection of Furosemide. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of stone free patients
Tidsramme: 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 |
At 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of urinary infection
Tidsramme: From baseline to 30 days
|
Rate of post-operative urinary tract infection will be assessed within 30 days after surgery on the combination of:
|
From baseline to 30 days
|
|
Pain in a scale
Tidsramme: 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) |
During the hospital stay
|
|
Opioid consumption
Tidsramme: During the hospital stay, an average of 1 day
|
The use of opioids will be reported |
During the hospital stay, an average of 1 day
|
|
Number of participants with adverse events
Tidsramme: From baseline to 3 months, an average of 1 day
|
Number of participants with Furosemide adverse events |
From baseline to 3 months, an average of 1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Mannlige urogenitale sykdommer
- Calculi
- Patologiske tilstander, anatomiske
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Urolithiasis
- Urinkalkuli
- Nefrolitiasis
- Patologiske tilstander, tegn og symptomer
- Nyreberegning
- Svovelforbindelser
- Organiske kjemikalier
- Amides
- Anilinforbindelser
- Aminer
- Sulfonamider
- Sulfanilamider
- Sulfoner
- Furosemid
Andre studie-ID-numre
- 2022-502890-40-00
- DR220258 (Annen identifikator: Promoter reference)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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