DEXmedetomidine作为PEDIAtric重症监护一线镇静用药对谵妄的影响 (PEDIADEX)
DEXmedetomidine作为儿科重症监护一线镇静用药对谵妄的影响：PEDIADEX随机对照试验
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :
• Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
研究概览
详细说明
- In the experimental group, participants will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.
The initial dose of dexmedetomidine continuous infusion is 0.7 µg/kg/h with increases of 0.2 µg/kg/h if needed associated to an opioid continuous infusion (sufentanil at 0.2 µg/kg/h or morphine at 40 µg/kg/h). A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 1.4 µg/kg/h for dexmedetomidine, 1.5 µg/kg/h for sufentanil and 300 µg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, midazolam at bolus or small doses (beginning between 20 µg/kg/h and 0.5 mg/h according to age/weight) are possible and will be reported.
- In the control group, participants with invasive ventilation will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours.
The initial dose of midazolam is 40 µg/kg/h for children <2 years, 60 µg/kg/h for children after 2 years, and 1 mg/h for children >40kg associated with sufentanil at 0.2 µg/kg/h or intravenous morphine at 40 µg/kg/h. A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 200 µg/kg/h and 10 mg/h if >40kg for midazolam and 1.5 µg/kg/h for sufentanil or 300 mcg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, are possible and noted. In case of failure, addition of dexmedetomidine will be possible only if midazolam is used at maximal doses.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Julie Chantreuil, Dr
- 电话号码：+33247478214
- 邮箱：j.chantreuil@chu-tours.fr
研究联系人备份
- 姓名：Lea Savary, Dr
- 电话号码：+33147474756
- 邮箱：l.savary@chu-tours.fr
学习地点
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Angers、法国、49933
- CHU d'Angers
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接触：
- Amandine Prenant, Dr
- 电话号码：+33241355088
- 邮箱：amandine.prenant@chu-angers.fr
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Caen、法国、14033
- CHU de Caen
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接触：
- David Brossier, Dr
- 电话号码：+33231063106
- 邮箱：brossier-d@chu-caen.fr
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Lille、法国、59120
- CHU de Lille
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接触：
- Stephane Leteurtre, Pr
- 电话号码：+33320445982
- 邮箱：stephane.LETEURTRE@chu-lille.fr
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Marseille、法国、13385
- CHU de Marseille
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接触：
- Fabrice Michel, Pr
- 电话号码：+33413429525
- 邮箱：fabrice.michel@ap-hm.fr
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Nantes、法国、44093
- CHU de Nantes
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接触：
- Bénédicte Gaillard-Leroux, Dr
- 电话号码：+33240083483
- 邮箱：benedicte.gaillardleroux@chu-nantes.fr
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Strasbourg、法国、67200
- CHU de Strasbourg
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接触：
- Charlie Demelo, Dr
- 电话号码：+33388127317
- 邮箱：charlie.demelo@chru-strasbourg.fr
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Tours、法国、37000
- CHU de Tours
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接触：
- Julie Chantreuil, Dr
- 电话号码：+33247478214
- 邮箱：j.chantreuil@chu-tours.fr
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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:
- Children between 1month to 17 years and 6 months
- Sedation and analgesia for mechanical ventilation for more than 12 hours
- Participants covered by or entitled to French social security
- Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s)
- Ability for participant to comply with the requirements of the study
- Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion
Exclusion Criteria:
- Patients under guardianship, curatorship or legal protection
- Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
- High-grade heart conduction disorder (Second or third-degree atrioventricular block)
- Status epilepticus
- Intracranial hypertension
- Sedation for more than 6 hours by benzodiazepines at the time of inclusion
- Need for paralytic medication (neuromuscular blocker) at admission to PICU
- Following cardiac surgery
- Palliative care on admission
- Significant bradycardia
- Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine
- Patient already enrolled in the study previously
- Expected duration of invasive mechanical ventilation inferior to 12 hours
- Hospitalized in a pediatric intensive care unit without computerized prescription software
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 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：dexmedetomidine
Participants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours. |
Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm |
|
有源比较器：midazolam
In the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours |
participant will receive midazolam as the comparator group |
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 |
|---|---|---|
|
Proportion of children with at least one episode of delirium during the ICU stay.
大体时间：From enrollment to the end of ICU stay, up to 90 days
|
Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9. |
From enrollment to the end of ICU stay, up to 90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sedation efficacy
大体时间：From enrollment to the end of sedation, up to 90 days
|
Investigators will assess:
|
From enrollment to the end of sedation, up to 90 days
|
|
Duration of delirium
大体时间：from enrollment to the end of ICU stay, up to 90 days
|
Investigators will assess the number of days with CAPD score higher than or equal to 9 |
from enrollment to the end of ICU stay, up to 90 days
|
|
Adverse events and serious adverse events
大体时间：From enrollment to the end of ICU stay, up to 90 days
|
Investigators will record:
|
From enrollment to the end of ICU stay, up to 90 days
|
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Mechanical ventilation
大体时间：From enrollment to extubation, for an average of 7 days
|
Investigators will report the mechanical ventilation time in hours |
From enrollment to extubation, for an average of 7 days
|
|
Health economic end points
大体时间：From enrollment to the end of hospital stay, up to 90 days
|
Investigators will assess the cumulative doses of IV sedative and analgesic drugs so we can compare:
|
From enrollment to the end of hospital stay, up to 90 days
|
|
Severity of delirium
大体时间：from enrollement to the end of hospital stay, up to 90 days
|
Investigators will assess the severity of delirium defined by the need for antipsychotic drugs |
from enrollement to the end of hospital stay, up to 90 days
|
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Need for re-intubation
大体时间：from enrollment, to the end of hospital stay, up to 90 days
|
Investigators will report the need for re-intubation post extubation |
from enrollment, to the end of hospital stay, up to 90 days
|
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Need for neurological investigations
大体时间：from enrollement to the end of hospital stay, up to 90 days
|
Investigators will report the percentage of brain imaging and electroencephalogramm |
from enrollement to the end of hospital stay, up to 90 days
|
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Length of stay
大体时间：from enrollement to the end of hospital stay, up to 90 days
|
Investigators will report
|
from enrollement to the end of hospital stay, up to 90 days
|
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Mortality
大体时间：from enrollement, to the end of follow-up, up to 90 days
|
Investigators will assess: hospital mortality |
from enrollement, to the end of follow-up, up to 90 days
|
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Withdrawal
大体时间：from enrollement to the end of ICU stay, up to 90 days
|
Investigators will assess the incidence of iatrogenic withdrawal syndrome, measured with WAT-score (defined by WAT > 4) |
from enrollement to the end of ICU stay, up to 90 days
|
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Associated sedation
大体时间：from enrollement, to the end of sedation, up to 90 days
|
Investigators will assess the daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group. |
from enrollement, to the end of sedation, up to 90 days
|
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Duration of sedation
大体时间：from enrollment, to the end of sedation, up to 90 days
|
Invesitgators will assess the number of days exposed to sedatives and opioids |
from enrollment, to the end of sedation, up to 90 days
|
合作者和调查者
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
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