Optimization of Hepatic Hemodynamics During Liver Surgery

NCT ID: NCT02993640

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-20

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.

Conditions

Portal Blood Pressure; Liver Surgery; Hepatic Hemodynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

vasopressin + nitro

vasopressin + nitroglycerin in simultaneous infusion

Group Type: EXPERIMENTAL

vasopressin + nitro

Intervention Type: DRUG

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

Interventions

vasopressin + nitro

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellinor Wisén

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven-Erik Ricksten, Professor

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

References

Wisen E, Svennerholm K, Bown LS, Houltz E, Rizell M, Lundin S, Ricksten SE. Vasopressin and nitroglycerin decrease portal and hepatic venous pressure and hepato-splanchnic blood flow. Acta Anaesthesiol Scand. 2018 Aug;62(7):953-961. doi: 10.1111/aas.13117. Epub 2018 Mar 26.

Reference Type: DERIVED

PMID: 29578250 (View on PubMed)

Other Identifiers

EPN879-13

Identifier Type: -

Identifier Source: org_study_id