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

Overview

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 Title of Study: “Utilization of Furosemide to Expedite Bladder Filling in Pediatric Females With Suspected Ovarian Torsion Awaiting Pelvic Ultrasound”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Diagnostic
  • Masking: Single (Participant)
• Study Primary Completion Date: April 2024

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.

Interventions

• Drug: Furosemide
  • 0.1mg/kg (max 5mg) of IV furosemide
• Drug: Normal saline
  • 20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush

Arms, Groups and Cohorts

• Experimental: Furosemide
  • Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose
• Placebo Comparator: IV fluids
  • Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush

Clinical Trial Outcome Measures

Primary Measures

• 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.

Secondary Measures

• 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
• 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
• The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US
  • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 8 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Connecticut Children’s Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Candice Jersey, Pediatric Emergency Medicine Fellow – Connecticut Children’s Medical Center
• Overall Official(s)
  • Candice Jersey, D.O., Principal Investigator, Connecticut Children’s Medical Center
• Overall Contact(s)
  • Candice Jersey, D.O., (860) 837-5596, cjersey@connecticutchildrens.org

Citations Reporting on Results

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Guthrie BD, Adler MD, Powell EC. Incidence and trends of pediatric ovarian torsion hospitalizations in the United States, 2000-2006. Pediatrics. 2010 Mar;125(3):532-8. doi: 10.1542/peds.2009-1360. Epub 2010 Feb 1.

Childress KJ, Dietrich JE. Pediatric Ovarian Torsion. Surg Clin North Am. 2017 Feb;97(1):209-221. doi: 10.1016/j.suc.2016.08.008.

Naffaa L, Deshmukh T, Tumu S, Johnson C, Boyd KP, Meyers AB. Imaging of Acute Pelvic Pain in Girls: Ovarian Torsion and Beyond☆. Curr Probl Diagn Radiol. 2017 Jul-Aug;46(4):317-329. doi: 10.1067/j.cpradiol.2016.12.010. Epub 2016 Dec 21.

Karaman E, Beger B, Cetin O, Melek M, Karaman Y. Ovarian Torsion in the Normal Ovary: A Diagnostic Challenge in Postmenarchal Adolescent Girls in the Emergency Department. Med Sci Monit. 2017 Mar 15;23:1312-1316. doi: 10.12659/msm.902099.

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Koff SA. Estimating bladder capacity in children. Urology. 1983 Mar;21(3):248. doi: 10.1016/0090-4295(83)90079-1. No abstract available.

Ross M, Selby S, Poonai N, Liu H, Minoosepehr S, Boag G, Eccles R, Thompson G. The Effect of a Full Bladder on Proportions of Diagnostic Ultrasound Studies in Children with Suspected Appendicitis. CJEM. 2016 Nov;18(6):414-419. doi: 10.1017/cem.2016.23. Epub 2016 Apr 4.

Shapira-Zaltsberg G, Fleming NA, Karwowska A, Trejo MEP, Guillot G, Miller E. Non-visualization of the ovaries on pediatric transabdominal ultrasound with a non-distended bladder: Can adnexal torsion be excluded? Pediatr Radiol. 2019 Sep;49(10):1313-1319. doi: 10.1007/s00247-019-04460-y. Epub 2019 Jul 9.

Ljungberg A, Segelsjo M, Dahlman P, Helenius M, Magnusson M, Magnusson A. Comparison of quality of urinary bladder filling in CT urography with different doses of furosemide in the work-up of patients with macroscopic hematuria. Radiography (Lond). 2021 Feb;27(1):136-141. doi: 10.1016/j.radi.2020.07.002. Epub 2020 Jul 26.

Helenius M, Segelsjo M, Dahlman P, et al. Comparison of four different preparation protocols to achieve bladder distension in patients with gross haematuria undergoing CT urography. Radiography 2012;18:206-11.

Van Der Molen AJ, Cowan NC, Mueller-Lisse UG, Nolte-Ernsting CC, Takahashi S, Cohan RH; CT Urography Working Group of the European Society of Urogenital Radiology (ESUR). CT urography: definition, indications and techniques. A guideline for clinical practice. Eur Radiol. 2008 Jan;18(1):4-17. doi: 10.1007/s00330-007-0792-x. Epub 2007 Nov 1.

Eades SK, Christensen ML. The clinical pharmacology of loop diuretics in the pediatric patient. Pediatr Nephrol. 1998 Sep;12(7):603-16. doi: 10.1007/s004670050514.

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