The aim of this double-blinded pilot randomized controlled trial (RCT) is to compare the effects of a conventional LCVP vs. a GDFT protocol in open liver surgery on surgical and anesthesiological conditions and its relation to outcome. Primary…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intraoperative blood loss
Secondary outcome
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 < 55 for more than 5, 10,15 minutes), vasopressor
use.
3) Outcome variables: kidney function after surgery (creatinine level, and
activation of RAAS system (plasma sodium (Na), aldosterone, ADH) in plasma and
urine (Na, Creatinine, K, ureum, osmolality). Other: morbidity, respiratory,
cardiovascular and neurologic events and surgical complications related to the
procedure.
4) Whether surgeons can perceive a difference in the surgical conditions)
created by a low central venous pressure and fluid restriction or a
goal-directed therapy anesthetic regimen.
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
The liver is one of the best perfused organs. Hence, liver surgery is renowned
for intraoperative hemorrhage and therefore its challenging hemodynamic and
fluid management. Suggested interventions to reduce blood loss and morbidity
almost all target at keeping a low central venous pressure (LCVP) and to
restrict fluid infusion before and during hepatic resection. The short-term
beneficial effects of LCVP on surgical operating conditions are at conflict
with a large body of literature on goal-directed fluid therapy (GDFT) showing
that optimization of dynamic preload parameters can half the morbidity related
to high risk surgery. Therefore, in clinical practice it is unknown which of
these two strategies to use during liver surgery.
Study objective
The aim of this double-blinded pilot randomized controlled trial (RCT) is to
compare the effects of a conventional LCVP vs. a GDFT protocol in open liver
surgery on surgical and anesthesiological conditions and its relation to
outcome. Primary outcome parameter is intra-operative blood loss. Secondary
outcomes are operating conditions as (subjectively) assessed by the surgeon,
hemodynamic conditions, postoperative kidney function and activation of RAAS
system and morbidity rate.
Study design
a single-center patient- and surgeon-blinded pilot RCT
Intervention
Arm 1: LCVP group: During the exploration and parenchyma transection phase an
absolute minimum of fluids are infused. CVP is aimed at < 5 mmHg. At the end of
the resection phase, fluids are infused until an intra-operative fluid balance
of 0-500+ is reached. Post-operatively, fluids will be infused according to the
attending clinicians discretion.
Arm 2: GDFT group: Patients will be treated according to a classic
goal-directed fluid regime aiming at stroke volume optimization. The GDFT
protocol is continued post-operatively until discharge to the surgical ward.
Study burden and risks
Both fluid regimes are used standardly in practice as are the medications used.
Extensive pre-clinical and clinical data are available. Thus, we expect no
additional risk to be taken by patient. Patients receive standard of care
regarding all other aspects.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Adult patients, undergoing open liver resection and which are able to provide written informed consent
Exclusion criteria
* 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)
* If no resection is performed
Design
Recruitment
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 |
|---|---|
| CCMO | NL55086.018.15 |