Optimization of Hepatic Hemodynamics During Liver Surgery

November 6, 2018 updated by: Ellinor Wisén, Sahlgrenska University Hospital, Sweden

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vasopressin + nitro
vasopressin + nitroglycerin in simultaneous infusion
Drug: vasopressin + nitro
vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Portal and hepatic venous flow after vasopressin and nitroglycerine infusion
Time Frame: six - nine months
six - nine months
Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion
Time Frame: six - nine months
six - nine months

Secondary Outcome Measures

Outcome Measure
Time Frame
lactate in the splanchnic circulation
Time Frame: six-nine months
six-nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Study Director: Sven-Erik Ricksten, Professor, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 20, 2017

Study Completion (Actual)

March 20, 2017

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN879-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans of sharing IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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