the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
2014年11月25日 更新者：Chen Yuanzhuo、Shanghai 10th People's Hospital
The aim of the study is to investigate the relationship of nocturnal use of eye masks and immune function, cerebral function and outcomes of patients with sepsis.
Thus more efficient and comprehensive treatment could be provided for patients in the duration of admission in intensive care unit.
研究概览
详细说明
- Treatment for patients There are no significant difference in standardized treatment received by patients enrolled, as well as the light equipment bedside and the food supply time. Patients are randomly divided into Eye Masks Group and Control Group by computer tools. Patients in Eye Masks Group are applied with eye masks from 22: 00 to 6: 00 each night during the admission. Blood sample was collected from each patient immediately after enrollment (D0), 6:30 of Day 1 (D1), Day 1 (D2), Day 3 (D3), Day 4 (D4) after admission. Urine of 6:00-21:00 and 21:00-6:00 is also stored from D0 to D4.
- Clinical data collection Data such as patient's age, gender, contact information, time from onset to admission, existence of septic shock, pathogen species, the site of infection, the existence of organ dysfunction, APACHE II score (Acute Physiology And Chronic Health Evaluation Scoring System) , SOFA （Sequential Organ Failure Assessment）score, the use of mechanical ventilation, vasoactive drugs, corticosteroids, sedative and analgesic medication, history of eye diseases and neurological diseases is collected from each patient who is included in the study. Follow-up data for daily daytime sleep time, existence of delirium, CPC score and GCS score on Day 7 and Day 28, length of stay and survival of 28 days after admission is also collected.
- Sample collection and processing The blood samples collected in citrate anticoagulation tubes and the urine samples collected in specialized graduated cylinders are stored at room temperature. Staining and fixation were performed within 24 h after blood collection. The expression of Monocyte Human Leukocyte Antigen-DR is detected using flow cytometer. The concentration of 6-sulfatoxymelatonin in urine is detected by ELISA kit.
- Cerebral Performance Category (CPC) CPC is a 5-category scale for measuring neurological status 2 weeks after cardiac arrest and CPC score 6 months after cardiac arrest. The 5 categories are: CPC 1, conscious and alert with good cerebral performance; CPC 2, conscious and alert with moderate cerebral performance; CPC 3, conscious with severe cerebral disability; CPC 4, comatose or in persistent vegetative state; and CPC 5, brain dead, circulation preserved.
- Glasgow Coma Scale (GCS) The GCS was developed as a standardized method for healthcare practitioners to evaluate degree of altered consciousness in patients who had sustained head injuries. The GCS is comprised of three categories: eye opening, verbal response, and motor response. The score from each category is summed, to provide a total GCS score (range 3-15).
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
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
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Shanghai、中国、200000
- Shanghai Tenth Hospital
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Transferred into ICU before 21:00 the same day;
- Consistent with the diagnosis of sepsis;
- Written informed consent was obtained from patients or their family members.
Exclusion Criteria:
- Age < 18 years;
- With sleep disorders; mental illness; cancer; autoimmune diseases; dysfunction of liver or kidney;
- History of using of immune-related drugs; melatonin receptor agonist or antagonist; sleep-aid or mental- related drugs;
- History of accepting radiotherapy or chemotherapy;
- Doing shift work before admission.
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
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
the patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night
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实验性的：Eye masks
the patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission
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eye masks from 21:00 to 6:00 each night during admission
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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参与者的生存
大体时间：住院后最多 28 天
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住院后最多 28 天
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cerebral Performance Category（CPC) of Participants
大体时间：up to 7 days after hospitalization
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up to 7 days after hospitalization
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Cerebral Performance Category（CPC) of Participants
大体时间：up to 28 days after hospitalization
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up to 28 days after hospitalization
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Glasgow Coma Scale (GCS) of Participants
大体时间：up to 7 days after hospitalization
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up to 7 days after hospitalization
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Glasgow Coma Scale (GCS) of Participants
大体时间：up to 28 days after hospitalization
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up to 28 days after hospitalization
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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
- 学习椅：Yuanzhuo Chen, M.D.、Shanghai 10th People's Hospital
- 首席研究员：Wenjie Li, M.D.、Shanghai 10th People's Hospital
- 首席研究员：Huiqi Wang, M.D.、Shanghai 10th People's Hospital
- 研究主任：Chengjin Gao, M.D.、Shanghai 10th People's Hospital
- 研究主任：Hu Peng, M.D.、Shanghai 10th People's Hospital
- 首席研究员：Yugang Zhuang, M.D.、Shanghai 10th People's Hospital
- 研究主任：Xiangyu Zhang, M.D.、Shanghai 10th People's Hospital
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
2014年12月1日
初级完成 (预期的)
2015年12月1日
研究完成 (预期的)
2016年2月1日
研究注册日期
首次提交
2014年11月24日
首先提交符合 QC 标准的
2014年11月25日
首次发布 (估计)
2014年12月1日
研究记录更新
最后更新发布 (估计)
2014年12月1日
上次提交的符合 QC 标准的更新
2014年11月25日
最后验证
2014年11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.
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