The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma Vitamin C level after administration of study drug
研究概览
简要总结
Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated.
详细描述
This study will be carried out in intensive care unit in Ain Shams University Hospitals , Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically ventilated which will be recruited into the study . After approval from ethical committee, an informed consent will be obtained from relatives of all patients. All data of patients will be confidential with secret codes and private file for each patient. Each patient's relative will receive an explanation for the purpose of the study. The study design will be prospective , randomized clinical trial.
Methodology:
All patients will be subjected to:
- Complete history taking.
- Full clinical examination
- Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature)
- CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days.
- Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or Female
- •Age from age≥18 years
- •Septic patient admitted to ICU and mechanically ventilated diagnosed by sepsis criteria proposed by the American College of Chest Physicians/Society of Critical Care Medicine
- •Expected to survive and remain in the ICU for at least 96 hours after study entry
排除标准
- •Age<18 years
- •Pregnant females
- •Patients with history of aspiration before intubation
- •Respiratory distress syndrome
- •Ischemic reperfusion injury
- •Cancer as the cause of SIRS or sepsis
- •Chronic kidney diseases
- •Ongoing shock
- •Allergy from interventional drug on the study
结局指标
主要结局
Plasma Vitamin C level after administration of study drug
时间窗: within 7 days of administered of vitamin C
Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
The Incidence of Ventilator -Associated Pneumonia ( VAP)
时间窗: within 28 days
Ventilator-associated pneumonia (VAP)is defined as pneumonia that occurs 48-72 hours or thereafter following endotracheal intubation, characterized by the presence of a new progressive infiltrate, signs of a systemic infection (fever, altered white blood cells count), changes in sputum characteristics, and detection of a causative agent
change in SOFA score
时间窗: within 7 days of administered of vitamin C
SOFA (Sepsis -related Organ Failure assessment) score
次要结局
- Ventilator-free days (28-days Cumulative )(28 days)
- changes in Glutathione Peroxidase enzyme (GPX) activity(within 7 days of administered of vitamin C)
- length of stay in intensive care unit(through the study completion, average 6 months)
- duration of vasopressor support(Average28 days)
- 28 day Mortality rate(average 28 days)
研究者
Wessam Adel El Sayed Abdel Aziz El Driny
principal investigator
Ain Shams University