Furosemide Use to Fill the Bladder of Pediatric Females Awaiting Pelvic Ultrasound

May 11, 2023 updated by: Candice Jersey, Connecticut Children's Medical Center

Utilization of Furosemide to Expedite Bladder Filling in Pediatric Females With Suspected Ovarian Torsion Awaiting Pelvic Ultrasound

The purpose of this study is to investigate whether or not furosemide causes the bladder to fill faster than IV fluids alone so that a pelvic ultrasound exam can be performed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Trans-abdominal pelvic ultrasound is the standard imaging modality for diagnosis of ovarian torsion in the pediatric population, however this requires that the patient have a full bladder at the time of imaging. This study will investigate whether low dose furosemide in addition to IV fluid boluses may provide a fast, effective, and non-invasive means to fill the bladder of pediatric females awaiting pelvic US. The target population are females age 8 to 18 years seen in the emergency room at Connecticut Children's Medical Center who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion. Enrolled patients will be randomized to the control (IVF bolus only) group vs. the intervention (IVF bolus + furosemide) group and will undergo point-of-care US (POCUS) and bladder scanner evaluation of the bladder every 30 minutes until the bladder is determined to be full.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lynn-Ann Sorbol
  • Phone Number: (860) 837-5596

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Principal Investigator:
          • Candice Jersey, D.O.
        • Sub-Investigator:
          • Henry Chicaiza, M.D.
        • Sub-Investigator:
          • Andrew Heggland, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Females age 8-18yrs seen in the ED at CCMC who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion
  2. Ability of patient (if 18yrs) or parent/legal guardian to sign a written informed consent

Exclusion Criteria:

  1. History of renal, genitourinary, or pelvic anomalies

    a. Eg: Chronic kidney disease, anuria, vesicoureteral reflux, ureteral obstruction, urologic reconstructive surgery, suprapubic or pelvic surgery, indwelling urethral catheter, oophorectomy, bicornate uterus

  2. Patients with multiple chronic illnesses or systemic neurologic abnormality

    a. Eg: Bronchopulmonary dysplasia, tracheostomy, gastrostomy tube dependence, cerebral palsy, severe developmental delay, mitochondrial disorder, congenital heart disease, cardiomyopathy, chronic kidney disease, diabetes

  3. Patients with known pregnancy

  4. Patients deemed to be critically ill

    a. Mental status changes, signs of end organ damage, hypotension

  5. Contraindication to giving Furosemide

    a. Allergy to sulfonamide medications, severe dehydration, hypotension, underlying electrolyte abnormality, underlying renal disease

  6. History of previous diuretic use within the past year
  7. Patients who self-report their bladder as being full at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furosemide
Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose
Drug: Furosemide
0.1mg/kg (max 5mg) of IV furosemide
Other Names:
  • Lasix
Placebo Comparator: IV fluids
Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush
Drug: Normal saline
20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush
Other Names:
  • Intravenous fluids
  • IV fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam
Time Frame: Through study completion, about 3 hours
Initiation of the intervention is defined as administration of furosemide vs. normal saline flush.
Through study completion, about 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between bladder volume as calculated on POCUS exam of a large, ovoid bladder and bladder volume as reported by bladder scanner
Time Frame: Through study completion, about 3 hours
Measurements will be completed every 30 minutes through study completion
Through study completion, about 3 hours
Number and nature of all reports of adverse events related to furosemide administration
Time Frame: From time of intervention until final disposition, about 6 hours
Adverse events include signs of severe dehydration, allergic reaction, and electrolyte abnormality
From time of intervention until final disposition, about 6 hours
The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US
Time Frame: About 3 hours
About 3 hours
The time from initiation of intervention to the time of admission or discharge order placement
Time Frame: From time of intervention until final disposition, about 6 hours
From time of intervention until final disposition, about 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Investigators

  • Principal Investigator: Candice Jersey, D.O., Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Torsion

Clinical Trials on Furosemide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe