Goal-directed versus restricted fluid management during major hepatic surgery; a double blind randomized controlled pilot trial

Goal-directed versus restricted fluid management during major hepatic surgery; a double blind randomized controlled pilot trial - Galileo trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45945

Enrollment

Registered

2016-02-24

Start date

2016-05-10

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid therapy during liver surgery

Interventions

Arm 1: LCVP group: During the exploration and parenchyma transection phase an absolute minimum of fluids are infused. CVP is aimed at

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients, undergoing open liver resection and which are able to provide written informed consent

Exclusion criteria

Exclusion criteria: * Known Pregnancy * Known allergies to colloid fluids or contrast * Pre-operative severe kidney dysfunction (GFR 1.5 of normal) and/or low albumin) * Significant ischemic heart disease, heart failure or severe arrhythmias * Laparoscopic liver resection * Minor resection (such as wedge resections) * If no resection is performed

Design outcomes

Primary

Measure	Time frame
Intraoperative blood loss	—

Secondary

Measure	Time frame
1) Surgical conditions (subjectively rated by the surgeon on a visual analogue scale from 0-10), duration of the liver resection phase, duration of Pringle maneuver), blood content in liver as measured by enhanced ultrasound (ESUS). 2) Anesthesiological conditions: fluid balance at end of surgery and 24 hours after surgery, hemodynamic values (cardiac output, stroke volume, systemic vascular resistance, heart rate, mean arterial pressure, heart rate), number of hypotensive episodes (MAP	—

Measure

Time frame

1) Surgical conditions (subjectively rated by the surgeon on a visual analogue scale from 0-10), duration of the liver resection phase, duration of Pringle maneuver), blood content in liver as measured by enhanced ultrasound (ESUS). 2) Anesthesiological conditions: fluid balance at end of surgery and 24 hours after surgery, hemodynamic values (cardiac output, stroke volume, systemic vascular resistance, heart rate, mean arterial pressure, heart rate), number of hypotensive episodes (MAP

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)