Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery
- Conditions
- Liver Surgery
- Registration Number
- NCT04092608
- Lead Sponsor
- Erasme University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
-All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device
-Atrial fibrillation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Urethral Perfusion index during surgery average of the Urethral Perfusion index values
- Secondary Outcome Measures
Name Time Method Stroke volume index during surgery average of stroke volume index during surgery
stroke volume variation during surgery average of stroke volume variation during surgery
cardiac index during surgery average of cardiac index during surgery
incidence of acute kidney injury At postoperative day 7 incidence of acute kidney injury measured with the KDIGO classification
Urethral Perfusion index during surgery average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery
Amount of vasopressors during surgery amount of vasopressors received during surgery
Amount of fluid during surgery during surgery amount of crystalloid received during the surgery
length of stay in the hospital Postoperative day 30 length of stay in the hospital
Incidence of postoperative complications Postoperative day 30 Incidence of postoperative complications
Trial Locations
- Locations (1)
Erasme Hospital
🇧🇪Brussels, Brussel-hoofdstad, Belgium
Erasme Hospital🇧🇪Brussels, Brussel-hoofdstad, Belgium