Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

Free University of Brussels (ULB)

Status: Completed

Conditions: Liver Surgery

Treatments: Procedure: GDFT; Procedure: LOW CVP (restrictive group)

Study type: Interventional

Funder types: Other

Identifiers

NCT04092608

B406201940521

Details and patient eligibility

About

"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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-Atrial fibrillation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Low CVP group (restrictive group)

Active Comparator group

Description:

Standard practice: the goal is to keep the CVP \< 7 mmHg during surgery. Baseline of crystalloid of 2ml/kg/h max in all patients. EV 1000 monitoring device (Edwards Lifesciences, Irvine, USA) will be used but values will be blinded to the anesthesiologist in charge of the patient. Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion Additionnal fluid administration is given to the patient at the end of the surgery (standard practice) UPi is blinded in all groups

Treatment:

Procedure: LOW CVP (restrictive group)

GDFT group

Experimental group

Description:

The goal is to keep stroke volume variation below 13% during surgery with mini fluid challenge of 100 ml of balanced crystalloid using the monitoring device (Edwards Lifesciences, Irvine, USA). Of course, the values will not be blinded to the anesthesiologist in charge of the patient. All patients have a baseline crystalloid: 2ml/kg/h and mini fluid challenges per 100 ml as described above. Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion UPi is blinded in all groups

Treatment:

Procedure: GDFT