Clinical trial NCT03779373: Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery
Official title: Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Goal Directed Fluid Therapy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: APHP
First posted: 2018-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.

Detailed description: Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.

To address this problem of consistency and protocol adherence, a clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.

A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery with a SVV \<13% with a reduced total amount of fluid administered without any difference in postoperative complications. Therefore the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard of care actually in the department) versus an Assisted fluid management approach (using the AFM mode) on the incidence of minor postoperative complications.

Eligibility criteria: Inclusion Criteria:

* All adult patients in the operating room scheduled for a major abdominal \& orthopedic surgery requiring a cardiac output monitoring (EV1000).
* Written informed consent received before surgery.

Exclusion Criteria:

* Minor Patients.
* No french speaking.
* Atrial fibrillation or severe arythmia.

Primary outcomes:
measure: composite criteria of minor postoperative complications
timeFrame: 30 days postsurgery
Secondary outcomes:
measure: Percentage of Time spent during the procedure with a stroke volume variation < 13%
timeFrame: Postoperative day 1
measure: Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2
timeFrame: Postoperative day 1
measure: composite criteria of major postoperative complications
timeFrame: 30 days postsurgery
measure: cardiac index over the procedure
timeFrame: Postoperative day 1
measure: stroke volume over the procedure
timeFrame: Postoperative day 1
measure: stroke volume variation over the procedure
timeFrame: Postoperative day 1
measure: Total Fluid received during the procedure
timeFrame: Postoperative day 1
measure: Net fluid balance
timeFrame: Postoperative day 1
measure: Postoperative acute care unit or intensive care unit length of stay
timeFrame: 30 days postsurgery
measure: Hospital length of stay
timeFrame: 30 days postsurgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Joosten Alexandre
state: Kremlin Bicetre
Study officials:
affiliation: Bicetre Hospital
name: Jacques Duranteau, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: APHP BICETRE
role: STUDY_CHAIR
References: