Oxidative Monitoring in ICU Patients.
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
- 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
- 是
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
Maria Karapetsa
MD
University of Thessaly
