Optimization of Hepatic Hemodynamics During Liver Surgery

Early Phase 1

Completed

• Conditions: Portal Blood Pressure; Liver Surgery; Hepatic Hemodynamics
• Interventions: Drug: vasopressin + nitro

• Registration Number: NCT02993640
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Primary Completion: 2017-03-20
• Study Completion: 2017-03-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vasopressin + nitro	vasopressin + nitro	vasopressin + nitroglycerin in simultaneous infusion

Primary Outcome Measures

Name	Time	Method
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion	six - nine months
Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion	six - nine months

Secondary Outcome Measures

Name	Time	Method
lactate in the splanchnic circulation	six-nine months