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临床试验/NCT01363635
NCT01363635招募中不适用

Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

Mahidol University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
incidence of severe sepsis/septic shock on admission to the general surgical ICU

研究概览

简要总结

Severe sepsis/septic shock are serious complications of infection with high morbidity and mortality. Recent information showed that early and aggressive resuscitation may help improving survival and outcome especially the resuscitation within the first 3 hours. In surgical patients, either severe sepsis/septic shock bought them to the operating room or this sepsis might be found after surgery resulting in higher morbidity and mortality. Not only knowledge management, others possible risk factors should also be identified and corrected for outcome improving. This prospective observational study will be done in 800 adult surgical patients admitting to the general surgical intensive care unit. Incidence of severe sepsis/septic shock on admission along with risk factors associated with poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of, stay, ICU death] will be recorded especially effect of amount and type of fluid replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Outcome as major organ failure, ICU length of stay, ICU, 28 and 90 days mortality will also be study.

详细描述

Consecutive severe sepsis/ septic shock patients who will be admitted to the general surgical ICU of Siriraj Hospital, Mahidol University, Bangkok, Thailand will be recruited to this study. Apart from demographic data (age, sex, BMI, comorbidity), detail of septic shock and resuscitation (preoperative and intraoperative resuscitation), vasopressor and steroid used, type and amount of fluid, blood and blood component used and shock reversal time. Complication associated with surgery, anesthesia and in ICU will also recorded. Clinical outcome as organ failure (Stroke, PMI, aki, ARDS); ventilator day, ICU and hospital length of stay, mortality (in ICU, 28 and 90 days mortality) and cause of mortality will be carefully recorded

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (> 18 years) surgical patient admitting to the general surgical ICU
  • Consent to this study

排除标准

  • Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery
  • Not consent to this study

结局指标

主要结局

incidence of severe sepsis/septic shock on admission to the general surgical ICU

时间窗: 5 year

Incidence of severe sepsis and septic shock on admission to the general surgical ICU

次要结局

  • risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death)(5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suneerat Kongsayreepong, MD

Professor

Mahidol University

研究点 (1)

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