Erasme Hospital
Brussels, Brussel-hoofdstad, 1070, Belgium
NCT Number: NCT04092608
"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).
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Brussels, Brussel-hoofdstad, 1070, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device
Exclusion criteria
-Atrial fibrillation
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.
Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.
Time frame: during surgery
average of the Urethral Perfusion index values
Time frame: during surgery
average of the Urethral Perfusion index values during the first 15-30 minutes of the surgery
Time frame: during surgery
average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery
Time frame: during surgery
amount of crystalloid received during the surgery
Time frame: during surgery
amount of vasopressors received during surgery
Time frame: during surgery
average of stroke volume index during surgery
Time frame: during surgery
average of stroke volume variation during surgery
Time frame: during surgery
average of cardiac index during surgery
Time frame: At postoperative day 7
incidence of acute kidney injury measured with the KDIGO classification
Time frame: Postoperative day 30
length of stay in the hospital
Time frame: Postoperative day 30
Incidence of postoperative complications
Erasme University Hospital
Other
Impact of Goal-directed Versus Restrictive Fluid Therapy on Urethral Tissue Perfusion in Hepatobiliary Surgery: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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