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Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients

2013年6月6日 更新者:Ayman Abd Al-maksoud Yousef、Tanta University

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

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

90

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

    • Algharbiya
      • Tanta、Algharbiya、埃及、35217
        • Tanta University

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

有资格学习的性别

全部

取样方法

概率样本

研究人群

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). Patients were classified into their groups at the time of the first blood analysis for these biomarkers at ICU admission.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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
Sepsis
Forty five patients developed septic complication during ICU stay (sepsis group).
SIRS group
Forty five patients were critically ill without evidence of infectious organism (SIRS 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
TNF-a determination using ELISA.
大体时间: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.
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.

次要结果测量

结果测量
措施说明
大体时间
Evaluation of SOFA score:
大体时间: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.
SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.
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.

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

  • 首席研究员:Ayman A Yousef, MD、Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2012年11月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2012年10月10日

首先提交符合 QC 标准的

2012年10月16日

首次发布 (估计)

2012年10月17日

研究记录更新

最后更新发布 (估计)

2013年6月7日

上次提交的符合 QC 标准的更新

2013年6月6日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1381/09/12

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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