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

Ovarian Torsion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098366
• Other study ID #: 21-008
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 29, 2021
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Connecticut Children's Medical Center
• Contact: Candice Jersey, D.O.
• Phone: (860) 837-5596
• Email: cjersey[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Torsion

Intervention

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

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

Dessie A, Steele D, Liu AR, Amanullah S, Constantine E. Point-of-Care Ultrasound Assessment of Bladder Fullness for Female Patients Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound in a Pediatric Emergency Department: A Randomized Controlled — View Citation

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. — View Citation

Guerra LA, Keays MA, Purser MJ, Wang SY, Leonard MP. Pediatric cystogram: Are we considering age-adjusted bladder capacity? Can Urol Assoc J. 2018 Dec;12(12):378-381. doi: 10.5489/cuaj.5263. — View Citation

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. — View Citation

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.

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. — View Citation

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

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 F — View Citation

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. — View Citation

Oh SW, Han SY. Loop Diuretics in Clinical Practice. Electrolyte Blood Press. 2015 Jun;13(1):17-21. doi: 10.5049/EBP.2015.13.1.17. Epub 2015 Jun 30. — View Citation

Prieto JM, Kling KM, Ignacio RC, Bickler SW, Fairbanks TJ, Saenz NC, Nicholson SI, Lazar DA. Premenarchal patients present differently: A twist on the typical patient presenting with ovarian torsion. J Pediatr Surg. 2019 Dec;54(12):2614-2616. doi: 10.1016 — View Citation

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. Ep — View Citation

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. — View Citation

Stranzinger E, Strouse PJ. Ultrasound of the pediatric female pelvis. Semin Ultrasound CT MR. 2008 Apr;29(2):98-113. doi: 10.1053/j.sult.2007.12.002. — View Citation

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 pract — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam	Initiation of the intervention is defined as administration of furosemide vs. normal saline flush.	Through study completion, about 3 hours
Secondary	The correlation between bladder volume as calculated on POCUS exam of a large, ovoid bladder and bladder volume as reported by bladder scanner	Measurements will be completed every 30 minutes through study completion	Through study completion, about 3 hours
Secondary	Number and nature of all reports of adverse events related to furosemide administration	Adverse events include signs of severe dehydration, allergic reaction, and electrolyte abnormality	From time of intervention until final disposition, about 6 hours
Secondary	The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US		About 3 hours
Secondary	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