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临床试验/NCT04893655
NCT04893655已完成4 期

Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年9月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
58
试验地点
1
主要终点
Changes in portal vein and caval vein pressures before and after dobutamine infusion

研究概览

简要总结

Maintaining adequate perfusion pressure and oxygen supply is essential for organ survival. Splanchnic hypoperfusion during the perioperative period in abdominal surgery may result in mucosal ischemia with increased permeability of the gut barrier. Additionally, the liver is also sensitive for hypoxemia and hypoperfusion, especially during liver surgery.

Anesthetics (such as propofol or sevoflurane) have a cardiovascular depressant effect, resulting in a reduction of cardiac output (CO). Dobutamine is used to counteract myocardial depressant effect of anesthetics. Additionally, dobutamine is frequently used during abdominal surgery to maintain splanchnic perfusion.

Dobutamine could increase hepatic blood flow (HBF) indirectly by increasing cardiac output or directly by stimulating adrenergic receptors in the splanchnic circulation. The hepatic circulation has a large number of alpha and beta adrenergic receptors and could be sensitive for adrenergic stimulation such as dobutamine. Hence, dobutamine could have a direct effect on the hepatic vasculature.

The aim of the study is to evaluate the effect of dobutamine on hepatic blood flow during goal directed hemodynamic therapy and to distinguish between potential direct and indirect effects.

详细描述

All patients receive standardized anesthesia care for pancreaticoduodenectomy according to the existing departmental protocol for these interventions.

All patients receive individualized goal-directed hemodynamic therapy based on the transpulmonary thermodilution technique.

At designated times, hemodynamic variables will be recorded. These include :

  • Heart rate (bpm)
  • Central venous pressure (mmHg)
  • Systolic arterial pressure (mmHg)
  • Diastolic arterial pressure (mmHg)
  • Mean arterial pressure (mmHg)
  • Cardiac index (L/min/m2)
  • Pulse pressure variation (PPV)
  • Stroke volume variation (SVV)

Measurements of hepatic flow and pressure will be 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

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 pancreaticoduodenectomy (Whipple's procedure).

排除标准

  • Allergy to the medication dobutamine.
  • Renal insufficiency (SCr > 2 mg/dL).
  • Severe heart failure (EF < 25%).
  • Hemodynamic unstable patients.
  • Atrial fibrillation.
  • Sinus tachycardia > 100 bpm on pre-operative electrocardiogram.
  • Severe coagulopathy (INR > 2).
  • Thrombocytopenia (< 80 x 103 /mcL).
  • End stage liver disease and/or portal hypertension.
  • Pregnancy and breastfeeding women.

研究组 & 干预措施

Dobutamine

Experimental

dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min

干预措施: Dobutamine Hydrochloride (Drug)

结局指标

主要结局

Changes in portal vein and caval vein pressures before and after dobutamine infusion

时间窗: from start anesthesia until end of anesthesia, up to a maximum of 11 hours

pressure measurements with 25gauge needle

change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine

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 portal venous resistance (PVR), during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :cardiac index, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :heart rate, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :blood pressure, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :central venous pressure, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :pulse pressure variation, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements :stroke volume variation, during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements : Systemic Vascular Resistance Index (SVRI), during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)
  • change in systemic hemodynamic measurements : Left Ventricular contractility (dPmx), during goal-directed hemodynamic therapy with dobutamine(from start anesthesia until end of anesthesia, up to a maximum of 11 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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