Optimization of Hepatic Hemodynamics During Liver Surgery

What Was Tested

In this early phase 1 trial, researchers set out to test Vasopressin for low blood pressure and orthostatic hypotension.

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

It had 1 arm (groups): vasopressin + nitro (experimental).

Vasopressin + nitroglycerin in simultaneous infusion.

The registry classes the interventions as drug.

More on the Plan

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.

Data will be collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be added.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients within ASA-class I-II scheduled for open liver resection.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: ASA-class III and IV, more than 2 medications for hypertension, BMI \> 35, technical difficulties with insertion av catheters, extensive surgery.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Vasopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-09 with completion listed for 2017-03-20.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 1 secondary outcome, for example lactate in the splanchnic circulation.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Vasopressin in 13 people with low blood pressure and orthostatic hypotension.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, Low blood pressure and orthostatic hypotension research.