Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- the incidence of PARDS
研究概览
简要总结
Biliary atresia is a serious congenital anomaly characterized by persistent and progressive cholestatic jaundice. The incidence of biliary atresia is more common in East Asia, especially China, with an incidence of 2 per 10,000 live births. Liver transplantation is the only effective way to treat end-stage liver disease. However, distant organ damage, affecting the heart, brain, kidneys, lungs, and intestines, is still an important factor affecting the long-term survival of children after surgery. Desflurane is a volatile anesthetic commonly used in surgery. In order to observe the effect of desflurane on the incidence of early postoperative pediatric acute respiratory distress syndrome (PARDS) with biliary atresia who underwent living donor liver transplantation, and explore the related mechanism, a total of 165 infant patients underwent living liver transplantation due to biliary atresia from March 2023 to October 2023 are included in our single-center prospective study. They are randomly divided into propofol group (n=55), propofol and desflurane group (n=55) and desflurane group (n=55) according to the difference of intraoperative anesthesia maintenance. Gender, age, height, weight, PELD scores and other preoperative basic data are recorded. Operation time, anhepatic time and intraoperative blood loss volume are recorded. The basic information of liver donors are also recorded. Postoperative mechanical ventilation time, ICU stay time, tacrolimus concentration, total length of hospital stay and mortality during hospitalization are recorded. According to the the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference is used as the diagnostic and grading criteria for postoperative PARDS, and the incidence and grading of PARDS within the first seven days after surgery are evaluated in the three groups. Peripheral blood is collected immediately after anesthesia induction, 30min after reperfusion and at the end of surgery to detect serum levels of HMGB1, IL-6 and TNF-α by enzyme linked immunosorbent assay (ELISA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis was biliary atresia
- •Living donors were either the father or the mother
- •3months ≤age ≤ 36 months
排除标准
- •The preoperative diagnosis was not biliary atresia
- •The donor was not a parent
- •Age <3months or>36 months
- •The patient had perinatal disease or congenital cardiopulmonary deformity
- •The patient had acute respiratory infection before surgery
- •The patient had hepatopulmonary syndrome
- •Retransplantation
研究组 & 干预措施
propofol and desflurane group
干预措施: desflurane (Drug)
propofol and desflurane group
干预措施: propofol (Drug)
propofol group
干预措施: propofol (Drug)
desflurane group
干预措施: desflurane (Drug)
结局指标
主要结局
the incidence of PARDS
时间窗: 7 days after LDLT
the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference
次要结局
- Interleukin-6(immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）)
- High mobility group box 1(immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）)
- Tumor necrosis factor-alpha(immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）)
研究者
Yimei, Cao
The First Central Clinical College of Tianjin Medical University
Tianjin First Central Hospital