Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
2021年4月9日 更新者:Children's Hospital of Philadelphia
In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits.
The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preventable.
The overarching goal for this study is to show that acute acquired structural and microstructural brain injury occurs in critically ill children with severe sepsis, and that this injury is related to neuropsychological deficits and impaired cerebral autoregulation (CAR).
Subjects will complete Magnetic resonance (MR) imaging within 2-10 days of recognition of their severe sepsis.
Subjects will undergo serial interrogation of CAR for up to 10 days.
CAR will be determined by the correlation of arterial blood pressure with middle cerebral artery flow velocity measured by transcranial doppler ultrasonography and cerebral oximetry derived from near-infrared spectroscopy.
Subjects will also participate in a neuropsychological evaluation 6 months after enrollment to evaluate multiple domains of behavior and cognition.
研究概览
研究类型
观察性的
注册 (实际的)
8
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- The Children's Hospital of Philadelphia
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Children admitted to the pediatric intensive care unit (PICU) at the Children's Hospital of Philadelphia (CHOP) with severe sepsis from an extracranial source and have no history of a preexisting underlying a neurologic disorder.
描述
Inclusion Criteria:
- Admission to the Children's Hospital of Philadelphia (CHOP) pediatric intensive care unit (PICU)
- Males or females ages ≥ 3.5 years and ≤ 18 years on day of sepsis recognition
- Meet published consensus criteria for severe sepsis or septic shock: a) ≥ 2 systemic inflammatory response syndrome criteria, b) suspected (based on attending physician) or confirmed systemic infection, and c) ≥ 2 or more organ system dysfunctions (severe sepsis) or cardiovascular dysfunction (septic shock).
- An indwelling arterial catheter.
- Parental/guardian permission (informed consent).
- The patient and parent/guardian are fluent in English.
Exclusion Criteria:
- History of neurologic disorder including (hypoxic ischemic injury, traumatic brain injury, epileptic encephalopathy, neurodevelopmental, neurometabolic or neurogenetic conditions, and structural brain anomalies).
- History of cancer or undergoing treatment for cancer.
- Meningitis or encephalitis as source of sepsis.
- Congenital heart disease.
- History of cardiac arrest.
- History of extracorporeal membrane oxygenation (ECMO) cannulation.
- Patients with contraindications to MR scanning.
- Pregnant or lactating females.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Previous enrollment in this study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Sepsis
Children with severe sepsis or septic shock
|
Conventional structural imaging will be combined with advanced neuroimaging modalities to evaluate integrity of white matter tracts, regional brain perfusion, and the 3-dimensional volume of specific brain structures.
|
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 |
---|---|---|
MRI
大体时间:2-10 days
|
Detection of signal abnormality on the patient's brain MRI scan.
|
2-10 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
CAR
大体时间:Daily for 10 days
|
Trends in functionality of CAR over the first 10 days of severe sepsis.
Identification of the optimal blood pressure range where CAR is most functional.
|
Daily for 10 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Matthew Kirschen, MD, PhD、CHOP
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月1日
初级完成 (实际的)
2019年9月27日
研究完成 (实际的)
2019年9月27日
研究注册日期
首次提交
2017年2月14日
首先提交符合 QC 标准的
2017年2月14日
首次发布 (实际的)
2017年2月16日
研究记录更新
最后更新发布 (实际的)
2021年4月12日
上次提交的符合 QC 标准的更新
2021年4月9日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MR imaging的临床试验
-
University of CalgaryAlberta Heritage Foundation for Medical Research; Calgary Health Region完全的
-
French Cardiology SocietyInstitut National de la Santé Et de la Recherche Médicale, France完全的
-
Medical Centre LeeuwardenUniversity of Groningen; LIMIS Development招聘中
-
National Institute of Diabetes and Digestive and...招聘中
-
Rabin Medical CenterRambam Health Care Campus; Hillel Yaffe Medical Center; US Department of Veterans Affairs; Assaf-Harofeh... 和其他合作者完全的
-
National Cancer Institute (NCI)招聘中