苯巴比妥用于激越性谵妄
苯巴比妥用于躁动性谵妄
The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers.
The main questions this trial aims to answer include:
- Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital?
- Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need?
Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium.
Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.
研究概览
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27704
- Duke Regional Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult Patients identified by providers to have agitated or hyperactive delirium
Exclusion Criteria:
- Pregnancy
- Incarceration
- Severe liver disease
- Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phenobarbital Therapy
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Phenobarbital Therapy will receive this drug according to a validated protocol similar to that in use for patients with alcohol withdrawal. Additional "rescue" medications including dexmedetomidine will be available as needed. |
Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness. |
|
有源比较器：Conventional Therapy
In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Conventional Therapy will receive antipsychotics as the primary medications for managing their agitation. Additional "rescue" medications including antipsychotics and dexmedetomidine will be available as needed. |
Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Provider Compliance
大体时间：Six months
|
The primary outcome of this study will be provider compliance with the study protocol assessed by selection of Conventional or Phenobarbital Therapy according to the designated month. |
Six months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital Length of Stay
大体时间：Six months
|
Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
Six months
|
|
ICU Length of Stay
大体时间：Six months
|
ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
Six months
|
|
Need for rescue medications
大体时间：Six months
|
Need for additional medications above the Phenobarbital or Conventional therapy regimens will be assessed to determine if patients receiving phenobarbital require fewer doses of additional medications. |
Six months
|
合作者和调查者
调查人员
- 首席研究员：Keith W. Van Dusen, M.D.、Duke University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pro00119911
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Only data pertaining to the primary and secondary objectives (e.g., hospital length of stay, doses of specific medications given, RASS assessments) will be shared. All data will be anonymized.
IPD 共享时间框架
Following completion of the study (Estimated late 2027), for 1 year.
IPD 共享访问标准
Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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