Clinical trial NCT05098366: Furosemide Use to Fill the Bladder of Pediatric Females Awaiting Pelvic Ultrasound
Official title: Utilization of Furosemide to Expedite Bladder Filling in Pediatric Females With Suspected Ovarian Torsion Awaiting Pelvic Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ovarian Torsion
Keywords: Pediatric
Point-of-care Ultrasound
Bladder volume
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam
timeFrame: Through study completion, about 3 hours
Secondary outcomes:
measure: The correlation between bladder volume as calculated on POCUS exam of a large, ovoid bladder and bladder volume as reported by bladder scanner
timeFrame: Through study completion, about 3 hours
measure: Number and nature of all reports of adverse events related to furosemide administration
timeFrame: From time of intervention until final disposition, about 6 hours
measure: The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US
timeFrame: About 3 hours
measure: The time from initiation of intervention to the time of admission or discharge order placement
timeFrame: From time of intervention until final disposition, about 6 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Candice Jersey, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
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