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Completed

NCT Number: NCT05098366

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

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.

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Key information

Conditions

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

Age range

8 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Furosemide

Drug

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

Other names: Lasix

normal saline

Drug

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

Other names: Intravenous fluids, IV fluids

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US

    Time frame: About 3 hours

  4. 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

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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