Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine
研究概览
简要总结
Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. For maintaining adequate blood pressure in a euvolemic patient, vasopressor therapy is required. Norepinephrine (NOR) is commonly used to treat anesthesia-related hypotension.
The hepatic circulation has a large number of alpha and beta adrenergic receptors and is very sensitive for adrenergic stimulation such as norepinephrine infusion. Animal studies (Hiltebrand et al.) suggest that NOR has only minimal effect on hepatic blood flow however the effect of NOR on hepatic blood flow in clinical surgical patients remains unclear.
The aim of the study is to evaluate the effect of NOR on hepatic blood flow during.
goal directed haemodynamic therapy.
详细描述
All patients receive standardized anesthesia care for pancreas surgery according to the existing departmental protocol for these interventions.
All patients receive individualized goal-directed haemodynamic therapy based on the transpulmonary thermodilution technique.
At designated times, hemodynamic variables will be recorded. These include:
- Heart rate (bpm)
- Central venous pressure (mmHg)
- Mean arterial pressure (mmHg)
- Cardiac index (L/min/m2)
- Pulse pressure variation (PPV)
Blood flow and pressure measurements performed by the surgeon :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult ≥ 18 years ≤ 80 years (female or male)
- •ASA I - II - III
- •Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
- •Patient is scheduled for pancreatic surgery.
排除标准
- •Allergy to the medication.
- •Renal insufficiency (SCr > 2 mg/dL).
- •Severe heart failure (EF < 25%).
- •Hemodynamic instable patients.
- •Atrial fibrillation.
- •Severe coagulopathy (INR > 2).
- •Thrombocytopenia (< 80 x 103 /mcL).
- •End stage liver disease.
- •Pregnancy and breastfeeding women
研究组 & 干预措施
norepinephrine
norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine
时间窗: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
pressure measurements with needle
change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine
时间窗: From start anesthesia until end of anesthesia, up to a maximum of 11 hours
flow measurements with echo probe
次要结局
- change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine(From start anesthesia until end of anesthesia, up to a maximum of 11 hours)
- amount of blood loss(from start of surgery until end of surgery, up to a maximum of 10 hours)
- amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrine(from start of surgery until end of surgery up to a maximum of 10 hours)
- change in cardiac index during goal-directed hemodynamic therapy with norepinphrine(From start anesthesia until end of anesthesia, up to a maximum of 11 hours)
- change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrine(From start anesthesia until end of anesthesia up to a maximum of 11 hours)