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

Early Phase 1

Completed

• Conditions: Ovarian Torsion
• Interventions: Drug: Furosemide; Drug: Normal saline

• Registration Number: NCT05098366
• Lead Sponsor: Connecticut Children's Medical Center

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.

Study Timeline

• Study Start: 2021-05-29
• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide	Furosemide	Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose
IV fluids	Normal saline	Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States