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临床试验/NCT01708772
NCT01708772已完成不适用

The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
TNF-a determination using ELISA.

研究概览

简要总结

A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.

详细描述

The patients staying in ICU for more than 24 hours were enrolled in the study. Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

研究设计

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

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

  • The patients staying in ICU for more than 24 hours were enrolled in the study.

排除标准

  • The Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure;
  • Patients received massive blood transfusion;
  • Patients with radiation therapy and patients with previous organ transplantation were excluded from the study.

结局指标

主要结局

TNF-a determination using ELISA.

时间窗: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.

A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R\&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.

次要结局

  • Evaluation of SOFA score:(Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.)

研究者

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

Ayman Abd Al-maksoud Yousef

Assistant Professor of Anesthesia

Tanta University

研究点 (1)

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