Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of pulmonary complications
研究概览
简要总结
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
详细描述
Objective
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were randomly divided into a standard hemodynamic management group (control group) and a goal-directed hemodynamic therapy group (GDHT group), with the control group guided by conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome were incidence of cardiac complications, pulmonary complications, neurological disease, acute kidney injury, and pain within 7 days postoperatively. Secondary outcome included microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the age is between 18 and 65 years old;
- •the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
- •patients will undergo the first operation after fluid resuscitation (after the shock period). The types of operation include incision decompression, escharectomy and skin grafting, and so on.
排除标准
- •Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
- •Patients or family members refusing informed consent for this study.
结局指标
主要结局
Incidence of pulmonary complications
时间窗: within 7 days postoperatively
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index \<300)
Incidence of cardiac complications
时间窗: within 7 days postoperatively
Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)
postoperative pain conditions
时间窗: within 7 days postoperatively
postoperative pain
Incidence of neurological complications
时间窗: within 7 days postoperatively
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Incidence of acute kidney injury
时间窗: within 7 days postoperatively
defined by acute kidney injury criteria.
次要结局
- Blood lactate(7 days after operation)
- Blood lacate(2 hours into the operation (T3))
- The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)(7 days after operation)
研究者
Liang Bing
associate chief physician
Guangzhou Red Cross Hospital