Galileo trial

GOAL-DIRECTED VERSUS RESTRICTED FLUID MANAGEMENT DURING MAJOR HEPATIC SURGERY; A DOUBLE BLIND RANDOMIZED CONTROLLED PILOT TRIAL

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22479

Enrollment

Registered

2016-04-04

Start date

2016-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Liver surgery, Liver cancer, intraoperative fluid therapy

Interventions

- GDFT - Low CVP

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Age 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) • Liver resections in combination with biliary tract resections • If no resection is performed

Design outcomes

Primary

Measure	Time frame
-Total intraoperative blood loss	—

Secondary

Measure	Time frame
28-okt-2016 amendment: - Kidney function day 1-5 (Na/K/Creat/Osm/Ureum, blood and (2x 12h a day) urine) - RAAS system (aldosterone, renine, ADH in plasma), just before and after resection during the operation - Outcome data: all complications - Body weight and ankle & abdominal girth (pre-op and day 1,2,5) - Microcirculatory measurements: - Sublingual measurements pre-op, during the surgery (T0 baseline (after skin incision), T1 (at the end of the ischemia phase, during the first VIO), T2 (30-60 minutes after reperfusion), 24, 48h and 5 days - Abdominal organ measurements during the surgery T0 baseline (after skin incision), T1 (at the end of the ischemia phase, during the first VIO), T2 (30-60 minutes after reperfusion). - Photo of liver tissue (to identify measured area with the Cytocam). - Liver tissue from the already resected part, for the use of the histology sample preparations	—

Measure

Time frame

28-okt-2016 amendment: - Kidney function day 1-5 (Na/K/Creat/Osm/Ureum, blood and (2x 12h a day) urine) - RAAS system (aldosterone, renine, ADH in plasma), just before and after resection during the operation - Outcome data: all complications - Body weight and ankle & abdominal girth (pre-op and day 1,2,5) - Microcirculatory measurements: - Sublingual measurements pre-op, during the surgery (T0 baseline (after skin incision), T1 (at the end of the ischemia phase, during the first VIO), T2 (30-60 minutes after reperfusion), 24, 48h and 5 days - Abdominal organ measurements during the surgery T0 baseline (after skin incision), T1 (at the end of the ischemia phase, during the first VIO), T2 (30-60 minutes after reperfusion). - Photo of liver tissue (to identify measured area with the Cytocam). - Liver tissue from the already resected part, for the use of the histology sample preparations

—

Contacts

Public ContactTimothy Mungroop

AMC

t.h.mungroop@amc.nl0031 6 22 14 64 88

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)