The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The effect of albumin supplementation on PCT level
研究概览
简要总结
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients.
The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.
详细描述
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients.
The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Admission to the intensive care unit (ICU) with sepsis or septic shock, or development of sepsis or septic shock during the ICU stay, as defined by the Sepsis-3 criteria
- •Serum albumin concentration below 30 g/L
- •Written informed consent provided by the participant or the participant's next of kin before enrollment
排除标准
- •Age younger than 18 years
- •Pregnancy
- •Any autoimmune disease
- •Refusal or absence of informed consent
- •Documented disease or treatment affecting the immune response, including:
- •Malignant hematological disease
- •Chronic systemic corticosteroid therapy
- •Biological therapy
- •Immunosuppressive treatment following organ transplantation
- •End-stage malignant disease
研究组 & 干预措施
Septic patients not receiving albumin replacement
Septic patients receiving albumin replacement
Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day
干预措施: Human albumin (Drug)
结局指标
主要结局
The effect of albumin supplementation on PCT level
时间窗: 24 months
The effect of albumin supplementation on the inflammatory and oxidative stress marker PCT will be assesed
The effect of albumin supplementation on CRP level
时间窗: 24 months
The effect of albumin supplementation on the inflammatory and oxidative stress marker CRP will be assesed
The effect of albumin supplementation on serum- total protein concentration
时间窗: 24 months
The effect of albumin supplementation on the inflammatory and oxidative stress markers total protein will be assesed
The effect of albumin supplementation on albumin concentration
时间窗: 24 months
The effect of albumin supplementation on the inflammatory and oxidative stress marker albumin will be assesed
Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5
时间窗: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5
Serum C-reactive protein (CRP) concentration was measured in mg/L. Changes over time were compared between the albumin-supplementation and control groups using repeated measurements from each participant.
次要结局
- Change From Baseline in Serum Procalcitonin(Baseline and daily through Day 5)
- Change From Baseline in Serum Total Antioxidant Capacity(Baseline, Day 3 and Day 5)
- Change From Baseline in Serum Albumin(Baseline and daily through Day 5)
- Change From Baseline in Plasma Reduced Glutathione(Baseline, Day 3 and Day 5)
- Change From Baseline in Plasma Protein Sulfhydryl Groups(Baseline, Day 3 and Day 5)
- Change From Baseline in Plasma Catalase Activity(Baseline and through Day 5)
- Change From Baseline in Plasma Myeloperoxidase Activity(Baseline and through Day 5)
- Change From Baseline in Serum Interleukin-1 Beta(Baseline and through Day 5)
- Change From Baseline in Serum Interleukin-6(Baseline and through Day 5)