Clinical trial NCT04092608: Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery
Official title: Impact of Goal-directed Versus Restrictive Fluid Therapy on Urethral Tissue Perfusion in Hepatobiliary Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Surgery
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Bicetre Hospital
First posted: 2019-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center randomized controlled superiority study
Primary purpose: TREATMENT

Brief summary: "Restrictive" fluid management is usually the current standard practice for patients undergoing liver surgery. The general idea is to maintain a low central venous pressure in order to decrease blood loss and improve the quality of the surgical field. However, this strategy , considered as rather "restrictive", can be associated with patient's harm, mainly acute kidney injury.

Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery which aimed to maintain normovolemia without being too liberal.

The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new IKORUS UP probe (Foley catheter made smarter with embedded photoplethysmographic sensing technology).

Detailed description: Restrictive fluid administration aiming at maintaining a low central venous pressure (low-CVP) during liver surgery has always been considered as a "gold standard" strategy because it decrease blood loss and improve the quality of the surgical field. However, this strategy , rather "restrictive", can be associated with patient harm (mainly AKI).

Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery.Some studies have shown that this strategy is feasible for such patient population.

There is currently a lack of data supporting the advantage of one strategy over the other in this patient population.While a restrictive fluid strategy can advantage the surgeon, it can also disadvantage the patient as in order to avoid hypotension, vasopressors administration is required. If the patient is hypovolemic, such strategy may cause acute kidney injury.

The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new Foley catheter with embedded photoplethysmographic sensing technology). This new technology allows for continuous and easy monitoring of urethral tissue perfusion

The investigators hypothesis is that patients in the GDFT group will have better Urethral Perfusion index (uPI) during surgery (via a better cardiac blood flow optimization) compared to patients in the restrictive (low CVP) group.

Eligibility criteria: Inclusion Criteria:

-All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device

Exclusion Criteria:

-Atrial fibrillation

Primary outcomes:
measure: Urethral Perfusion index
timeFrame: during surgery
Secondary outcomes:
measure: Urethral Perfusion index
timeFrame: during surgery
measure: Urethral Perfusion index
timeFrame: during surgery
measure: Amount of fluid during surgery
timeFrame: during surgery
measure: Amount of vasopressors
timeFrame: during surgery
measure: Stroke volume index
timeFrame: during surgery
measure: stroke volume variation
timeFrame: during surgery
measure: cardiac index
timeFrame: during surgery
measure: incidence of acute kidney injury
timeFrame: At postoperative day 7
measure: length of stay in the hospital
timeFrame: Postoperative day 30
measure: Incidence of postoperative complications
timeFrame: Postoperative day 30
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
state: Brussel-hoofdstad
Study officials:
affiliation: ERASME
name: Alexandre Joosten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chirnoaga D, Coeckelenbergh S, Ickx B, Van Obbergh L, Lucidi V, Desebbe O, Carrier FM, Michard F, Vincent JL, Duranteau J, Van der Linden P, Joosten A. Impact of conventional vs. goal-directed fluid therapy on urethral tissue perfusion in patients undergoing liver surgery: A pilot randomised controlled trial. Eur J Anaesthesiol. 2022 Apr 1;39(4):324-332. doi: 10.1097/EJA.0000000000001615.