Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

NCT ID: NCT04092608

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-04
• Study Completion Date: 2020-07-30

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.

Conditions

Liver Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low CVP group (restrictive group)

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

Group Type: ACTIVE_COMPARATOR

LOW CVP (restrictive group)

Intervention Type: PROCEDURE

Goal = CVP \< 7mmHg and only 2 ml/kg/h max during surgery.

GDFT group

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

Group Type: EXPERIMENTAL

GDFT

Intervention Type: PROCEDURE

The titration of fluid will be based on stroke volume variation. The goal is to maintain this variable \< 13% during surgery with multiple mini fluid challenge of 100 ml of balanced crystalloid.

Interventions

GDFT

The titration of fluid will be based on stroke volume variation. The goal is to maintain this variable \< 13% during surgery with multiple mini fluid challenge of 100 ml of balanced crystalloid.

Intervention Type: PROCEDURE

LOW CVP (restrictive group)

Goal = CVP \< 7mmHg and only 2 ml/kg/h max during surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-Atrial fibrillation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bicetre Hospital

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Joosten, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Joosten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

ERASME

Locations

Erasme Hospital

Brussels, Brussel-hoofdstad, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34669645 (View on PubMed)

Other Identifiers

B406201940521

Identifier Type: -

Identifier Source: org_study_id