The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Improvement in ARDS patient's mortality rate
研究概览
简要总结
- To access role of vitamin C supplementation in ARDS patients on the following:
Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from mechanical ventilator Incidence of adverse drug reaction 2. To access tolerability of vitamin C supplementation in patients with ARDS.
详细描述
Acute Respiratory distress syndrome (ARDS) is a form of severe hypoxemic respiratory failure due to severe impairment of gas exchange and lung mechanics that is characterized by inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich edema fluid into the air space. Current ARDS antioxidant treatment strategy, is based upon supportive therapies including low tidal volume ventilation, fluid management, nutritional support and glucocorticoids.
Ascorbic acid or Vitamin C is an important dietary water-soluble antioxidant, it significantly decreases the adverse effects of ROS such as reactive oxygen and nitrogen species that can cause oxidative damage to macromolecules. Recent studies show that high dose of Vitamin C have protective effects against overwhelming oxidative stress due to critical illness. Vitamin C improves immune function and improves tissue perfusion and reduce tissue hypoxia and subsequent organ dysfunction. Also, Ascorbate, the redox form of vitamin C is physiological antioxidant and has bacteriostatic activity Hence the study aims to evaluate the impact of IV Vitamin C in ARDS, as a novel pharmaceutical approach in an attempt to improve the clinical outcome of ARDS patients, decrease other medications toxicities and improve patients' quality of life.
The objective of the current study was to evaluate the efficacy, safety and tolerability of IV Vitamin C administration in addition to conventional therapy in patients with ARDS by assessing the following:
-
Oxidants/ antioxidants imbalance
-
Length of hospital stay
-
Mortality rate
-
Weaning from mechanical ventilator
-
Incidence of adverse drug reaction
-
Serum IL8 levels
-
Serum Vitamin C levels
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis
- •who don't have an exclusion criteria will be included.
排除标准
- •Known allergy to Vitamin C
- •Inability to obtain consent;
- •Age < 18 years;
- •More than 48 hours since meeting ARDS criteria;
- •Pregnancy or breast feeding,
- •Moribund patient not expected to survive 24 hours;
- •Patients not eligible to CPR
- •Active kidney stone
结局指标
主要结局
Assessment of Improvement in ARDS patient's mortality rate
时间窗: within 10 days of ARDS diagnosis
Days to weaning from ventilator
次要结局
- Intensive Care Unit Length of Stay(subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first)
- Duration of Mechanical Ventilation(subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 10 days from time of enrollment, whichever is first)
研究者
Nada Hazem Farrag
Assistant Lecturer
Misr International University