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NCT Number: NCT04092608

Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

"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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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, Brussel-hoofdstad, 1070, Belgium

About this study

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.

Who can participate

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

Treatment and study plan

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.

LOW CVP (restrictive group)

Procedure

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

Primary outcomes

  1. Urethral Perfusion index

    Time frame: during surgery

    average of the Urethral Perfusion index values

Secondary outcomes

  1. Urethral Perfusion index

    Time frame: during surgery

    average of the Urethral Perfusion index values during the first 15-30 minutes of the surgery

  2. Urethral Perfusion index

    Time frame: during surgery

    average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery

  3. Amount of fluid during surgery

    Time frame: during surgery

    amount of crystalloid received during the surgery

  4. Amount of vasopressors

    Time frame: during surgery

    amount of vasopressors received during surgery

  5. Stroke volume index

    Time frame: during surgery

    average of stroke volume index during surgery

  6. stroke volume variation

    Time frame: during surgery

    average of stroke volume variation during surgery

  7. cardiac index

    Time frame: during surgery

    average of cardiac index during surgery

  8. incidence of acute kidney injury

    Time frame: At postoperative day 7

    incidence of acute kidney injury measured with the KDIGO classification

  9. length of stay in the hospital

    Time frame: Postoperative day 30

    length of stay in the hospital

  10. Incidence of postoperative complications

    Time frame: Postoperative day 30

    Incidence of postoperative complications

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Bicetre Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2019
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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