No registrations found.
ID
Source
Brief title
Health condition
Liver surgery, Liver cancer, intraoperative fluid therapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Total intraoperative blood loss
Secondary outcome
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
Background summary
NA
Study objective
The use of a GDFT protocol during liver surgery instead of the widely used LCVP regimen has no influence on blood loss.
Study design
pre-op until day 5
Intervention
- GDFT
- Low CVP
Inclusion criteria
Adult 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5677 |
| NTR-old | NTR5821 |
| Other | METC : 2016_004 |