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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04092608
Other study ID # B406201940521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2019
Est. completion date July 30, 2020

Study information

Verified date August 2020
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 40
Est. completion date July 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

-Atrial fibrillation

Study Design


Related Conditions & MeSH terms


Intervention

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.
LOW CVP (restrictive group)
Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.

Locations

Country Name City State
Belgium Erasme Hospital Brussels Brussel-hoofdstad

Sponsors (2)

Lead Sponsor Collaborator
Erasme University Hospital Bicetre Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urethral Perfusion index average of the Urethral Perfusion index values during surgery
Secondary Urethral Perfusion index average of the Urethral Perfusion index values during the first 15-30 minutes of the surgery during surgery
Secondary Urethral Perfusion index average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery during surgery
Secondary Amount of fluid during surgery amount of crystalloid received during the surgery during surgery
Secondary Amount of vasopressors amount of vasopressors received during surgery during surgery
Secondary Stroke volume index average of stroke volume index during surgery during surgery
Secondary stroke volume variation average of stroke volume variation during surgery during surgery
Secondary cardiac index average of cardiac index during surgery during surgery
Secondary incidence of acute kidney injury incidence of acute kidney injury measured with the KDIGO classification At postoperative day 7
Secondary length of stay in the hospital length of stay in the hospital Postoperative day 30
Secondary Incidence of postoperative complications Incidence of postoperative complications Postoperative day 30
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