Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Syndecan 1 (ng/mL)
研究概览
简要总结
Evaluate the of effect of alpha-lipoic acid in critically ill septic patients. 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .
详细描述
- Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhour University & Ethics committee of Damanhur National Medical National Institute.
- All participants or their relatives should agree to take part in this clinical study and will provide informed consent.
- 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- The primary outcomes were evaluated as follows: organ dysfunction via the SOFA score, systemic inflammation via IL-6 and CRP, oxidative stress via malondialdehyde (MDA), endothelial glycocalyx integrity via syndecan-1, and 28-day mortality as clinical outcome. Secondary outcomes included 90-day survival, the number of ventilator-free days within 28 days, the duration of vasopressor therapy, and both ICU and overall hospital length of stay. Exploratory outcomes included changes in kidney function (serum creatinine) and liver function (ALT, AST).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be diagnosed with sepsis or develop sepsis during their ICU length of stay
- •Age 18 year and older
- •Patient able to receive oral or enteral medication
排除标准
- •Patients who will be diagnosed with septic shock
- •Female patients who are pregnant or lactating.
- •Participation in another clinical trial.
- •Current treatment with other medications that have antioxidant effects, such as vitamin C and vitamin E.
- •Allergy to LA or similar active agents (e.g., vitamin B), or previous intolerance to the recommended dose of LA
研究组 & 干预措施
Placebo Group
control group: 40 septic patients will receive placebo daily for seven days.
干预措施: Placebo (Other)
ALA group
ALA group: 40 septic patients will be given 1800 mg for seven days .
干预措施: Alpha-lipoic acid (Dietary Supplement)
结局指标
主要结局
Syndecan 1 (ng/mL)
时间窗: 1 Week
glycocalyx degradation marker
IL-6 (pg/mL)
时间窗: 1 Week
Inflammatory marker
CRP (mg/L)
时间窗: 1 Week
Inflammatory marker
Sequential Organ Failure Assessment (SOFA) Score
时间窗: 1 week
The SOFA score is a composite score based on the degree of dysfunction in six organ systems-respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ dysfunction scores from 0 to 4, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention. The higher the SOFA score, the higher the likely mortality.
次要结局
- ICU and hospital stay(28 days)
- ventilator-free days within 28 days(28 days)
- the duration of vasopressor therapy(1 Week)
研究者
Rehab Werida
Associate Professor
Damanhour University