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Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

NCT04092608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-08-11

No results posted yet for this study

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).

Conditions

  • Liver Surgery

Interventions

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.

PROCEDURE

LOW CVP (restrictive group)

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

Sponsors & Collaborators

  • Bicetre Hospital

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Alexandre Joosten, MD PhD · ERASME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092608 on ClinicalTrials.gov