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NCT05270421
Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi
Phase 3 trial testing Furosemide 40 mg in Urolithiasis in 500 participants. Status unknown.
31 March 2022
Quick facts
| Lead sponsor | Shiraz University of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 1 July 2020 |
| Primary completion | 31 March 2022 |
| Estimated completion | 30 July 2022 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Furosemide 40 mg — full drug profile →
- Conventional Treatment — full drug profile →
Conditions studied
- Urolithiasis — all drugs for Urolithiasis →
- Nephrolithiasis — all drugs for Nephrolithiasis →
- Urinary Calculi — all drugs for Urinary Calculi →
- Ureterolithiasis — all drugs for Ureterolithiasis →
Sponsor
Shiraz University of Medical Sciences
Who can join
Adults 18 to 60, any sex, with Urolithiasis or Nephrolithiasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients. The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05270421
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05270421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shiraz University of Medical Sciences
- Last refreshed: 8 March 2022
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