Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

Liver Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092608
• Other study ID #: B406201940521
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-Atrial fibrillation

Related Conditions & MeSH terms

• Liver Surgery

Intervention

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.
• LOW CVP (restrictive group)
Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels	Brussel-hoofdstad

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Bicetre Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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