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

Connecticut Children's Medical Center

Status and phase: Completed; Early Phase 1

Conditions: Ovarian Torsion

Treatments: Drug: Normal saline; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT05098366

21-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Furosemide

Experimental group

Description:

Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose

Treatment:

Drug: Furosemide

IV fluids

Placebo Comparator group

Description:

Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush

Treatment:

Drug: Normal saline