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Clinical Trials/NCT02993640
NCT02993640CompletedEarly Phase 1

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 sites13 target enrollmentStarted: September 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Sponsor
Enrollment
13
Primary Endpoint
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

vasopressin + nitro

Experimental

vasopressin + nitroglycerin in simultaneous infusion

Intervention: vasopressin + nitro (Drug)

Outcomes

Primary Outcomes

Portal and hepatic venous flow after vasopressin and nitroglycerine infusion

Time Frame: six - nine months

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

Time Frame: six - nine months

Secondary Outcomes

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

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ellinor Wisén

MD

Sahlgrenska University Hospital, Sweden

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