Optimization of Hepatic Hemodynamics During Liver Surgery

Liver Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993640
• Other study ID #: EPN879-13
• Status: Completed
• Phase: Early Phase 1
• Start date: September 2016
• Est. completion date: March 20, 2017

Study information

• Verified date: November 2018
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hepatic Hemodynamics
• Liver Surgery
• Portal Blood Pressure

Intervention

Drug:
• vasopressin + nitro
vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portal and hepatic venous flow after vasopressin and nitroglycerine infusion		six - nine months
Primary	Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion		six - nine months
Secondary	lactate in the splanchnic circulation		six-nine months