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临床试验/NCT04928859
NCT04928859已完成不适用

Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 364 人开始时间: 2014年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
364
主要终点
the mortality of the patients

研究概览

简要总结

To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • TBSA≥ 20% (TBSA,the total burn area.)
  • Admitted to hospital within 24 hours after injury.

排除标准

  • 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

研究组 & 干预措施

the albumin group

The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group.

干预措施: Albumin (Drug)

结局指标

主要结局

the mortality of the patients

时间窗: during the patients's hospitalization, an average of 1-2 month.

The mortality of the patients during their hospitalization.

次要结局

  • the length of the patients's hospital stay(during the patients's hospitalization, an average of 1-2 month.)
  • the number of patients that using ventilators(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(during the patients's hospitalization, an average of 1-2 month.)
  • the number of complications that the patients occurred(during the patients's hospitalization, an average of 1-2 month.)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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