Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
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.
調査の概要
詳細な説明
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.
Potential study subjects will be recruited from the Children's Healthcare of Atlanta - Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling urinary catheter for >48 hours will be included. For this pilot study, the investigators will enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a service other than Critical Care Medicine will have clearance from the primary team prior to approaching for enrollment. The consent process will take place prior to or during the initial 24 hours of urinary catheter placement.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30329
- Children's Helathcare of Atlanta at Egleston
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Alcohol Level
時間枠：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.
|
up to 3 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Urine Analysis
時間枠：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.
|
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, for a total of 3 days. A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria. A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock. |
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.
|
協力者と研究者
捜査官
- 主任研究者：Jana A Stockwell, MD、Children's Healthcare of Atlanta
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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