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临床试验/NCT02114853
NCT02114853Unknown不适用

Oxidative Monitoring in ICU Patients.

University of Thessaly1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Sepsis severity

研究概览

简要总结

Sepsis is common in the ICU and is associated with high mortality that reaches up to 60%, increased duration of hospitalization and additional costs [1,2].Early diagnosis and stratification of severity are of great importance in order to timely apply proper and adequate treatment [3].

Oxidative stress is implicated in inflammation and sepsis and sepsis severity seems to correlate with increased oxidative stress [7,8]. Monitoring of oxidative stress has been done so far with various markers which reflect the different pathways of oxidative stress as is oxidosis of lipids, proteins, nucleic acids; yet the antioxidant capacity of various enzymes and vitamins has been studied [9]. However these methods do not reflect oxidative stress as a whole, are time consuming, need special laboratory procedures and are costly.

Oxidation-reduction potential is a new technique that enables bedside assessment of the oxidative status. It is based on measuring the balance of oxidants and reductants in human blood with a simple plasma test that reports results immediately.

Hypothesis

Oxidation-reduction potential, used for oxidative monitoring in ICU patients, might correlate with sepsis severity and may be used in addition to other clinical and/or inflammatory markers to assess severity and possibly prognosis.

详细描述

  1. Procedures/evaluation of the trial 4.1 Evaluation at entry

The selected oxidative parameters that will be assessed in this study will be:

oxidation-reduction potential (ORP) in plasma thiobarbituric acid-reactive substances (TBARS) in plasma protein carbonyls (CO) in plasma total antioxidant capacity in plasma (TAC)

The inflammatory parameters that will be measured are:

C-Reactive protein in plasma Brain Natriuretic Peptide (BNP) in whole blood Troponin-I in whole blood Soluble CD14 subtype presepsin ( sCD14-ST) in whole blood

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects entering to the ICU and are expected to stay for more than 72 hours are eligible to participate.
  • Sepsis is recognized, defined and categorized according to the Surviving Sepsis Campaign criteria [10].

排除标准

  • i) patients who receive chronic renal replacement therapy, iii) age under 18, iv) patients with body mass index<18, v) antioxidant supplementation two weeks prior to ICU admission

结局指标

主要结局

Sepsis severity

时间窗: Time of sepsis diagnosis

次要结局

  • mortality(28th day)
  • ICU outcome(within 28 days)

研究者

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

Maria Karapetsa

MD

University of Thessaly

研究点 (1)

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