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Trial record 11 of 242 for:    furosemide

Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

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ClinicalTrials.gov Identifier: NCT02960412
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.

Condition or disease Intervention/treatment Phase
Cystoscopy Drug: furosemide Drug: Normal Saline Phase 4

Detailed Description:

Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.

The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: furosemide
furosemide 10mg (1mL) IV push for one dose
Drug: furosemide
10mg lasix given intraoperatively
Other Name: Lasix

Placebo Comparator: placebo
normal saline 1mL IV push for one dose
Drug: Normal Saline
Normal saline given intraoperatively as placebo




Primary Outcome Measures :
  1. time to ureteral patency [ Time Frame: intra-operative ]
    time to confirmation of ureteral patency in seconds


Secondary Outcome Measures :
  1. adverse effects from furosemide administration [ Time Frame: immediately post operative (1-3 days post operatively) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergoing any urogynecologic surgery
  • No allergy or contraindication to receiving furosemide
  • Normal Creatinine/glomerular filtration rate

Exclusion Criteria:

  • Unable to consent, including if non English speaking
  • Allergy or contraindication to receiving furosemide
  • Intraoperative injury to the lower urinary tract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960412


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02960412     History of Changes
Other Study ID Numbers: Pro00026976
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action