Utilization of Furosemide to Expedite Bladder Filling in Pediatric Females With Suspected Ovarian Torsion Awaiting Pelvic Ultrasound
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Furosemide
Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose
干预措施: Furosemide (Drug)
IV fluids
Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush
干预措施: Normal saline (Drug)
结局指标
主要结局
The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam
时间窗: Through study completion, about 3 hours
Initiation of the intervention is defined as administration of furosemide vs. normal saline flush.
次要结局
- 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)
研究者
Candice Jersey
Pediatric Emergency Medicine Fellow
Connecticut Children's Medical Center