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临床试验/NCT02993640
NCT02993640已完成早期 1 期

Effects of Vasopressin and Nitroglycerine in Combination on Splanchnic Blood Flow, and on Hepatic and Portal Venous Pressures in Liver Resection

Sahlgrenska University Hospital, Sweden0 个研究点目标入组 13 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
13
主要终点
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion

研究概览

简要总结

The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery.

详细描述

The patients in this study (undergoing elective liver resection) will be anesthetized according to routine practice in our hospital. A radial arterial catheter and a central venous catheter will be inserted, as well as a femoral arterial catheter for Picco monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients will be recruited, and the total data collection is estimated to be completed and assessed after six to nine months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients within ASA-class I-II scheduled for open liver resection

排除标准

  • ASA-class III and IV, more than 2 medications for hypertension, BMI > 35, technical difficulties with insertion av catheters, extensive surgery.

研究组 & 干预措施

vasopressin + nitro

Experimental

vasopressin + nitroglycerin in simultaneous infusion

干预措施: vasopressin + nitro (Drug)

结局指标

主要结局

Portal and hepatic venous flow after vasopressin and nitroglycerine infusion

时间窗: six - nine months

Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion

时间窗: six - nine months

次要结局

  • lactate in the splanchnic circulation(six-nine months)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellinor Wisén

MD

Sahlgrenska University Hospital, Sweden

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