Norepinephrine Boluses for Prevention of Postreperfusion Syndrome in Living Donor Liver Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of postreperfusion syndrome
研究概览
简要总结
We study the efficacy of Norepinephrine boluses on prevention of postreperfusion syndrome during living donor liver transplantation.
NE and Post-reperfusion:
On portal vein declamping, we will start rapid 500 ml 4% albumin infusion or packed RBCs (according to the anhepatic hemoglobin level 5 min before declamping) through 14 Gauge peripheral venous cannula in all patients.
NE boluses technique; We will inject NE boluses in the C.V.P port of the pulmonary artery catheter with 5 ml saline flushing after each. After reperfusion, we will start bolus noradrenaline 20 µg if mean arterial blood pressure (mABP) decreases by 10 % or more of the basal reading (immediately before portal vein declamping after ensuring withholding of the surgical manipulation). Additional NE boluses will be given as follow;
- If mABP rises to 65 mmHg (lowest target level), we will hold NE boluses.
- If mABP remains constant or begins to rise but did not reach 65 mmHg, we will give 20 µg after 10 seconds from the previous bolus
- If mABP continues to drop, we will add 10 µg to the previous dose after 10 seconds and can be repeated.
- If mABP remains below 65 mmHg more than 1 minute, we will give the scheduled bolus NE with adding 10 µg adrenaline boluses.
详细描述
Anesthesia technique:
On admission to the pre-anesthetic room, patients will receive intravenous pantoprazole sodium 40 mg, midazolam 0.02 mg/kg and the prophylactic antibiotics.
In the operating room, we apply standard monitors in the form of pulse oximetry, non-invasive blood pressure, and electrocardiography. Induction of anesthesia will be fentanyl 2 µg/kg, propofol 1-2 mg/kg, and rocuronium bromide 0.8 -1 mg/kg.
After tracheal intubation, we will insert an arterial catheter in the radial artery of the non-dominant hand after performing modified Allen's test. Then, we will insert five port pulmonary artery catheter for continuous cardiac output monitoring (the equipment).
Anesthesia will be maintained by sevoflurane in 40% oxygen with infusion of fentanyl 0.5-1 µg/kg/h and rocuronium bromide 200-400 µg /kg/h. We adopt goal directed fluid replacement protocol keeping the target mABP of 65 mmHg using norepinephrine in fluid non-responders with low SVR (German medical association 2009). Crystalloids will be Ringer's Acetate and the colloid will be albumin 4% in Ringer Acetate solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •All patients subjected to living donor liver transplantation with right lobe liver graft.
排除标准
- •Acute fulminant hepatitis
- •Chronic hypertension
- •Moderate to severe valvular heart disease
- •Chronic kidney disease (CKD) and Hepatorenal syndrome (HRS)
- •Preoperative S.Cr elevation > 1.4 mg/kg or dialysis recently before surgery
- •Long standing diabetes mellitus (> 10 years on insulin)
- •Moderate and sever Porto-pulmonary hypertension
- •Moderate and sever Hepato-pulmonary syndrome (HPS)
- •Contraindications to pulmonary artery catheter insertion
- •Budd Chiari syndrome
- •Re-transplantation
- •Massive blood transfusion (more than 5 units of blood before portal clamping)
- •Graft/weight ratio > 1.4 and < 0.8
研究组 & 干预措施
Norepinephrine boluses
Single arm study
干预措施: Norepinephrine boluses (Drug)
结局指标
主要结局
Incidence of postreperfusion syndrome
时间窗: 5 minutes after reperfusion
PRS defined as 30% drop in the mABP when compared to the mABP just before portal declamping sustained for 1 min within the first 5 min after portal unclamping
次要结局
- Liver graft function(After 2 days postoperative)
- Acute kidney injury(within the first 2 days postoperative)
- 3-month survival(90 days after surgery)
- Ischemia(During and 5 minutes after norepinephrine boluses)
- Arrhythmia(During and 5 minutes after norepinephrine boluses)
- one-year survival(one year after transplantation)