Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.
研究概览
详细说明
A retrospective case-control study was conducted.
Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified.
Patients were divided into two groups according to the severity of burns, the patients with a 20%<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group.
The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.
研究类型
观察性的
注册 (实际的)
364
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 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The patients who admitted to the burn ward of the Second Affiliated Hospital, School of Medicine, Zhejiang University and needed fluid resuscitation were identified during the period of January 2011 to December 2018.
描述
Inclusion Criteria:
- Age ≥ 18
- TBSA≥ 20% （TBSA，the total burn area.）
- Admitted to hospital within 24 hours after injury.
Exclusion Criteria:
- STB ≥ 33 μ mol/L
- Cr ≥ 171 μ
- Urine output l< 500 ml / 24 h
- Pregnant and lactating women
- Severe combined injury
- Glucocorticoids users
- Immunosuppressants users
- Patients survived less than 48 hours
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 |
|---|---|
|
the albumin group
The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group.
|
At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group. The patients who have no albumin use during their hospitalization in the burn ward consisted the control group.
其他名称：
|
|
the control group
The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control 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 |
|---|---|---|
|
the mortality of the patients
大体时间：during the patients's hospitalization, an average of 1-2 month.
|
The mortality of the patients during their hospitalization.
|
during the patients's hospitalization, an average of 1-2 month.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the length of the patients's hospital stay
大体时间：during the patients's hospitalization, an average of 1-2 month.
|
the Length of the patients's hospital stay,an average of 1-2 month.
|
during the patients's hospitalization, an average of 1-2 month.
|
|
the number of patients that using ventilators
大体时间：during the patients's hospitalization, an average of 1-2 month.
|
the number of patients who using ventilators during their hospitalization
|
during the patients's hospitalization, an average of 1-2 month.
|
|
Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid
大体时间：during the patients's hospitalization, an average of 1-2 month.
|
the volume of the patients's resuscitation fluid using "mL" as the measurement
|
during the patients's hospitalization, an average of 1-2 month.
|
|
the number of complications that the patients occurred
大体时间：during the patients's hospitalization, an average of 1-2 month.
|
the number of complications that the patients occurred during their hospitalization
|
during the patients's hospitalization, an average of 1-2 month.
|
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
- 研究主任：Hai-Bin Dai, doctor、Second Affiliated Hospital, School of Medicine, Zhejiang University
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)
2014年6月1日
初级完成 (实际的)
2019年1月1日
研究完成 (实际的)
2020年7月30日
研究注册日期
首次提交
2021年6月2日
首先提交符合 QC 标准的
2021年6月9日
首次发布 (实际的)
2021年6月16日
研究记录更新
最后更新发布 (实际的)
2021年6月16日
上次提交的符合 QC 标准的更新
2021年6月9日
最后验证
2014年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.