FIRE Stones : Impact of Furosemide on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser : a controlled two-parallel group multicenter trial with blinding evaluation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

4 Jan 2024 → ongoing

Decision date (initial)

2023-09-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To show that the injection of 40 mg of Furosemide in slow intravenous during 10 minutes after the procedure, increases the stone-free rate 3 months after a flexible ureteroscopy for destruction of kidney stones with laser.

Secondary objectives 5

1. To show that the rate of early post-operative urinary tract infection (within the first post-operative month) after flexible ureteroscopy with laser destruction of kidney stones is lower in patients who received forced diuresis with injection of Furosemide.
2. Evaluation of post-operative pain.
3. Safety of the use of Furosemide in patients treated by flexible ureteroscopy for renal stone laser destruction.
4. Effect of the prescription of an alpha-blocker as usual treatment on stone-free rate, which will be assessed in a subgroup analysis.
5. Evaluation of agreement between the imaging analysis of the urologist and the specialized radiologists.

Conditions and MedDRA coding

Destruction of kidney stones

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female ≥ 18 years old < 80 years old
2. With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
3. Person affiliated to a French social security system or equivalent
4. Written informed consent obtained from the participant
5. Ability for participant to comply with the requirements of the study
6. Stones of less than 3 cm

Exclusion criteria 9

1. Contra-indication to Furosemide: o Hyper-sensitivity to the active substance or one of the excipients o Hyper-sensitivity to Sulfonamide o Renal failure with oligo-anuria refractory to Furosemide o Hypokalemia < 3,5 mmol/L o Severe hyponatremia o Hypovolemia with or without hypotension or dehydration o Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
2. Patient having Furosemide as usual treatment
3. Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
4. Participation in other interventional research with an investigational drug or medical device
5. 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)
6. Hepatic insufficiency due to the risk of hepatic encephalopathy
7. Hepatorenal syndrome
8. Hypoproteinemia especially in case of nephrotic syndrome
9. Drug-drug interactions with furosemide especially the lithium

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 5

1. 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.
2. Post-operative pain will be assessed using a numerical pain scale ranging from 0 to 10 in the recovery room, in the service and at the discharge.
3. Furosemide adverse events will be assessed.
4. Effect of the prescription of an alpha-blocker will be looked at considering the primary outcome
5. Evaluation of agreement between the imaging analysis of the urologist and the specialized radiologist will be looked at considering the primary outcome. Urologists will assess CT-Scan while the study is going on while specialized radiologists will assess the CT Scan at the end of the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours Cedex 9

Postcode

37044

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

LETOUCHE Marie-Lou

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

LETOUCHE Marie-Lou

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications