Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

NCT04092608 | Completed

• 1 other identifier: B406201940521
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Surgery

Outcome Measures

Primary Outcomes (1)

• Urethral Perfusion index

  average of the Urethral Perfusion index values

  during surgery

Secondary Outcomes (10)

• Urethral Perfusion index

  during surgery

• Urethral Perfusion index

  during surgery

• Amount of fluid during surgery

  during surgery

• Amount of vasopressors

  during surgery

• Stroke volume index

  during surgery

Study Arms (2)

Low CVP group (restrictive group)

ACTIVE COMPARATOR

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)

GDFT group

EXPERIMENTAL

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

Interventions

GDFT 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.

GDFT group

LOW CVP (restrictive group) PROCEDURE

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

Low CVP group (restrictive group)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Atrial fibrillation

Sponsors & Collaborators

• Erasme University Hospital: lead
• Bicetre Hospital: collaborator

Study Sites (1)

Erasme Hospital

Brussels, Brussel-hoofdstad, 1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34669645 DERIVED

Study Officials

• Alexandre Joosten, MD PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center randomized controlled superiority study

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 17, 2019
• Study Start: September 4, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)