RecruitingPhase 3NCT05916963

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

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


Sponsor

University Hospital, Tours

Enrollment

374 participants

Start Date

Jan 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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

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Interventions

DRUGFurosemide 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.


Locations(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

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NCT05916963


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