Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

Impact of Goal-directed Versus Restrictive Fluid Therapy on Urethral Tissue Perfusion in Hepatobiliary Surgery: A Prospective Randomized Controlled Trial

"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).

Study Overview

• Status: Completed
• Conditions: Liver Surgery
• Intervention / Treatment: Procedure: LOW CVP (restrictive group); Procedure: GDFT

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel-hoofdstad
    • Brussels, Brussel-hoofdstad, Belgium, 1070
      • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Atrial fibrillation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: LOW CVP (restrictive group); Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.
Experimental: 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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethral Perfusion index	average of the Urethral Perfusion index values	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethral Perfusion index	average of the Urethral Perfusion index values during the first 15-30 minutes of the surgery	during surgery
Urethral Perfusion index	average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery	during surgery
Amount of fluid during surgery	amount of crystalloid received during the surgery	during surgery
Amount of vasopressors	amount of vasopressors received during surgery	during surgery
Stroke volume index	average of stroke volume index during surgery	during surgery
stroke volume variation	average of stroke volume variation during surgery	during surgery
cardiac index	average of cardiac index during surgery	during surgery
incidence of acute kidney injury	incidence of acute kidney injury measured with the KDIGO classification	At postoperative day 7
length of stay in the hospital	length of stay in the hospital	Postoperative day 30
Incidence of postoperative complications	Incidence of postoperative complications	Postoperative day 30

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Bicetre Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B406201940521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No