Clinical Study of the Effect of Intravenous Vitamin C on the Prognosis and Sublingual Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 28-d Mortality
研究概览
简要总结
This pilot study intends to observe the effect of intravenous vitamin C on the prognosis and sublingual microcirculation in patients with vasoplegia syndrome after cardiac surgery through a prospective randomized controlled study method.
详细描述
Vasoplegia syndrome is a frequent and severe complication after cardiac surgery (incidence 5-50%), marked by hypotension, normal/high cardiac index, and continuous vasopressor need, leading to prolonged ICU stay, acute kidney injury, and death. Its pathophysiology involves systemic inflammation, excessive nitric oxide, vasopressin depletion, and endothelial dysfunction impairing microcirculation.
Vitamin C, a potent antioxidant, scavenges reactive oxygen species, protects glycocalyx, supports norepinephrine synthesis, and limits iNOS expression, improving microperfusion in experimental models. Plasma vitamin C drops significantly after cardiopulmonary bypass, suggesting increased consumption and potential benefit.
However, clinical evidence is conflicting. Neither trial assessed microcirculatory endpoints, leaving this gap unexplored in randomized studies. Thus, this study aims to evaluate vitamin C's effects on both shock duration and sublingual microcirculation in post-cardiac surgery vasoplegia, addressing the unresolved clinical and mechanistic questions.
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
- Double (Participant, 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
- •Age 18-85 years;
- •Patients who develop vasoplegia syndrome within 6 hours after being admitted to the ICU following cardiac surgery
- •Signing informed consent.
排除标准
- •Emergency surgery;
- •Sepsis shock, postoperative cardiogenic shock or hemorrhagic shock;
- •Pregnancy or lactation;
- •Allergy to vitamin C;
- •Inability to obtain clear sublingual microcirculatory images due to any cause;
- •Judgment by the attending physician that the patient was unsuitable for enrollment.
研究组 & 干预措施
vitamin C and standard care
Patients in the intervention group received IV vitamin C (1.5g every 6 hours).
干预措施: Vit C (Drug)
standard care
Patients in the control group received nothing.
干预措施: Standard Preparation (Drug)
结局指标
主要结局
28-d Mortality
时间窗: 28 days after treatment
patients with sepsis who died after treatment from any cause within 28 days
shock duration
时间窗: 28 days after treatment
The primary outcome was shock duration, defined as the time from the start of vasopressor therapy to the complete discontinuation of all vasopressors. Complete discontinuation defined as no vasopressor being administered to maintain a MAP \>65 mmHg for a consecutive period of 24 hours.
次要结局
- Perfused vessel density (PVD)(48 hours after treatment)
- proportion of perfusion vessels(48 hours after treatment)
- Lactate clearance, 48h, %(48 hours after treatment)
- proportion of perfused vessels (PPV)(24 hours after treatment)
- perfused vessel density (PVD)(24 hours after treatment)
- heterogeneity index (HI)(24 hours after treatment)
- ICU length of stay(28 days after treatment)
- mechanical ventilation duration(28 days after treatment)
- 28-d Mortality(28 days after treatment)
研究者
Jingyuan,Xu
Clinical Professor
Southeast University, China