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Galileo trial


- candidate number24184
- NTR NumberNTR5821
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2016
- Secondary IDsMETC 2016_004 
- Public TitleGalileo trial
- Scientific TitleGOAL-DIRECTED VERSUS RESTRICTED FLUID MANAGEMENT DURING MAJOR HEPATIC SURGERY; A DOUBLE BLIND RANDOMIZED CONTROLLED PILOT TRIAL
- ACRONYMGALILEO
- hypothesisThe use of a GDFT protocol during liver surgery instead of the widely used LCVP regimen has no influence on blood loss.
- Healt Condition(s) or Problem(s) studiedLiver tumor, Surgery, Fluid management
- Inclusion criteriaAdult patients, undergoing open liver resection and which are able to provide written informed consent
- Exclusion criteria Age < 18
Known pregnancy
Known allergies to colloid fluids or contrast
Pre-operative severe kidney dysfunction (GFR < 30).
Severe decreased liver function disorders (i.e. PTT, APTT > 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-aug-2017
- Target number of participants40
- Interventions- GDFT
- Low CVP
- Primary outcome- Total intraoperative blood loss
- Secondary outcome- Need for blood, plasma or platelet transfusion
- Duration of liver resection phase
- Duration of Pringle maneuver
- Duration of the total operation
- Liver blood volume as measured by contrast enhanced ultrasound (CEUS)
- Fluid balance at the end and 24 hours after surgery
- Given fluid on ward
- Vasopressor use
- Time spent above target SV
- The ability of surgeons to estimate to which group the patient is randomized
- Kidney function after 0, 24 and 48 hours
- IL-6 at 0, 24, 48 hours
- RAAS system (aldosterone, renine, ADH in plasma, electrolytes), urine: 24-hours urine sample for sodium, potassium and creatine excretion, pre-op, 24, 48h and 5 days
- Outcome data: all complications
- Daily body weight and ankle & abdominal girth
- Timepointspre-op until day 5
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMC Timothy Mungroop
- CONTACT for SCIENTIFIC QUERIESMC Timothy Mungroop
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)28-okt-2016: amendment

Exclusion criteria NOT APPLICABLE:
Liver resections in combination with biliary tract resections

Secondary outcomes CHANGED:
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
- RECORD4-apr-2016 - 28-okt-2016


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