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Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04092608
Enrollment
40
Registered
2019-09-17
Start date
2019-09-04
Completion date
2020-07-30
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Surgery

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.

Interventions

PROCEDUREGDFT

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.

PROCEDURELOW CVP (restrictive group)

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

Sponsors

Bicetre Hospital
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Single center randomized controlled superiority study

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

-Atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
Urethral Perfusion indexduring surgeryaverage of the Urethral Perfusion index values

Secondary

MeasureTime frameDescription
incidence of acute kidney injuryAt postoperative day 7incidence of acute kidney injury measured with the KDIGO classification
length of stay in the hospitalPostoperative day 30length of stay in the hospital
Incidence of postoperative complicationsPostoperative day 30Incidence of postoperative complications
Urethral Perfusion indexduring surgeryaverage of the Urethral Perfusion index values during the first 15-30 minutes of the surgery
cardiac indexduring surgeryaverage of cardiac index during surgery
Amount of vasopressorsduring surgeryamount of vasopressors received during surgery
Stroke volume indexduring surgeryaverage of stroke volume index during surgery
stroke volume variationduring surgeryaverage of stroke volume variation during surgery
Amount of fluid during surgeryduring surgeryamount of crystalloid received during the surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026