Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Perfused vessel density (PVD)
研究概览
简要总结
This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.
详细描述
This prospective, double-blind, randomized, controlled trial enrolled septic shock patients admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and vitamin B1 added to standard care) and the control group (hydrocortisone alone added to standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24 hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD. We further validated the primary outcome by observing differences in renal perfusion monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the control group.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock
- •A dose of norepinephrine (>15ug/min)
- •Age ≥18 and ≤80 years old
- •Signing Informed Consent
排除标准
- •Meet the inclusion criteria for more than 12 hours
- •Clinician judges that corticosteroid therapy should not be used
- •Uncontrolled malignancy
- •Glucocorticoid therapy was used within seven days before admission.
- •Expected death within 24 hours
- •The sublingual microcirculation cannot be measured
研究组 & 干预措施
Glucocorticoid combination therapy Group
Hydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours.
干预措施: Glucocorticoid combination therapy (Drug)
Glucocorticoid Group
Hydrocortisone 200mg continuous intravenous infusion(24h)
干预措施: Glucocorticoid (Drug)
结局指标
主要结局
Perfused vessel density (PVD)
时间窗: 24 hours after treatment
Determinant of capillary diffusive capacity
次要结局
- lactate(24 hours after treatment)
- proportion of perfusion vessels(24 hours after treatment)
- total vascular density(24 hours after treatment)
- microvascular flow index(24 hours after treatment)
- renal contrast-enhanced ultrasound parameters(24 hours after treatment)
研究者
Jingyuan,Xu
Clinical Professor
Southeast University, China