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

NCT05098366 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 21-008
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Torsion

Keywords

Pediatric; Point-of-care Ultrasound; Bladder volume

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Number and nature of all reports of adverse events related to furosemide administration

  From time of intervention until final disposition, about 6 hours

• 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

Study Arms (2)

Furosemide

EXPERIMENTAL

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

Drug: Furosemide

IV fluids

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Furosemide DRUG

0.1mg/kg (max 5mg) of IV furosemide

Also known as: Lasix

Furosemide

Normal saline DRUG

20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush

Also known as: Intravenous fluids, IV fluids

IV fluids

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females age 8-18yrs seen in the ED at CCMC who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion
• Ability of patient (if 18yrs) or parent/legal guardian to sign a written informed consent

You may not qualify if:

• 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
• 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
• Patients with known pregnancy
• Patients deemed to be critically ill
• a. Mental status changes, signs of end organ damage, hypotension
• Contraindication to giving Furosemide
• a. Allergy to sulfonamide medications, severe dehydration, hypotension, underlying electrolyte abnormality, underlying renal disease
• History of previous diuretic use within the past year
• Patients who self-report their bladder as being full at the time of enrollment

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (16)

• 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/j.jpedsurg.2019.08.020. Epub 2019 Aug 30.

  PMID: 31500875 RESULT

• 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.

  PMID: 20123766 RESULT

• 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.

  PMID: 27894428 RESULT

• 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.

  PMID: 28185689 RESULT

• 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.

  PMID: 28296829 RESULT

• 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 Trial. Ann Emerg Med. 2018 Nov;72(5):571-580. doi: 10.1016/j.annemergmed.2018.04.010. Epub 2018 Jul 3.

  PMID: 29980460 RESULT

• 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.

  PMID: 18450135 RESULT

• 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.

  PMID: 29940135 RESULT

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

  PMID: 6836800 RESULT

• 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.

  PMID: 27039941 RESULT

• 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.

  PMID: 31289908 RESULT

• 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.

  PMID: 32727709 RESULT

• 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.

  RESULT

• 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.

  PMID: 17973110 RESULT

• 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.

  PMID: 9761364 RESULT

• 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.

  PMID: 26240596 RESULT

MeSH Terms

Conditions

Ovarian Torsion

Interventions

Furosemide; Saline Solution; Fluid Therapy

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Therapy; Therapeutics

Study Officials

• Candice Jersey, D.O.

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: October 28, 2021
• Study Start: May 29, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)