Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Blood Alcohol Level
研究概览
简要总结
Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.
Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.
详细描述
This study involves a confirmatory/refuting approach to the above stated hypothesis. The investigators will test this hypothesis by addressing the following aims/objectives:
Specific Aim 1:
Quantify blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized in the Pediatric Intensive Care Unit.
Specific Aim 2:
Compare cellular components in urinalyses after the introduction of the ethanol locks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months - 17 years
- •Urinary catheter placed at Children's Healthcare of Atlanta
- •Anticipated urinary catheter need for > 48 hours
- •Parent or legal guardian (or patient when applicable) consent for enrollment.
排除标准
- •18 yo or older.
- •Urosepsis at time of study enrollment
- •Known bladder or genitourinary abnormalities
- •Chronic bladder drainage regimen
- •Urologic surgeries (as part of the current admission)
- •Medical urgency preventing timely administration of the consenting process, or any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
- •Anuria or oliguria (<0.5 cc/kg/hr averaged over the previous 12 hours)
- •Other technical considerations that would prevent the timely acquisition of sufficient samples such as (but not limited to) absence of a study team member.
- •Parent or legal guardian (or patient when applicable) refuses to sign informed consent.
研究组 & 干预措施
Ethanol lock
Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
干预措施: Ethanol Lock (Drug)
结局指标
主要结局
Blood Alcohol Level
时间窗: up to 3 days
An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.
次要结局
- Urine Analysis(Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.)
研究者
Jana Stockwell
M.D.
Children's Healthcare of Atlanta