Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery (AFM)

Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Goal Directed Fluid Therapy
• Intervention / Treatment: Other: Use of a decision support system on the EV1000 monitor (AFM mode)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Kremlin Bicetre
    • Paris, Kremlin Bicetre, France, 94270
      • Joosten Alexandre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: EV1000 monitoring; This group of patients will receive fluid administration during surgery based on a manual GDFT protocol actually in place in the department using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)	Other: Use of a decision support system on the EV1000 monitor (AFM mode); The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)
EXPERIMENTAL: EV1000 monioring with the decision (AFM); This group of patients will receive fluid administration during surgery based on a novel clinical decision support system for GDFT guidance using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)	Other: Use of a decision support system on the EV1000 monitor (AFM mode); The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite criteria of minor postoperative complications	This composite score includes 8 items : postoperative nausea and vomiting; delirium and confusion; Infection of surgical site; urinary infection; acute kidney injury (KDIGO I & II classiciation); paralytic ileus; other infection (skin, catheter, unknown etc); Readmission to the hospital within 30 days postoperative	30 days postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time spent during the procedure with a stroke volume variation < 13%	Percentage of Time spent during the procedure with a stroke volume variation < 13%	Postoperative day 1
Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2	Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2	Postoperative day 1
composite criteria of major postoperative complications	This composite score includes 14 items : stoma dehiscence; Peritonitis; Sepsis; wound dehiscence; bleeding requiring a redo surgery; pulmonary embolism; pulmonary edema; Pneumonia; acute coronary syndrome; atrial fibrillation; stroke; Dialysis; non scheduled redo surgery; 30days mortality (all causes)	30 days postsurgery
cardiac index over the procedure	average cardiac index over the surgery	Postoperative day 1
stroke volume over the procedure	average stroke volume over the procedure	Postoperative day 1
stroke volume variation over the procedure	average stroke volume variation over the procedure	Postoperative day 1
Total Fluid received during the procedure	amount of fluid received during surgery	Postoperative day 1
Net fluid balance	Net fluid balance at the end of the ICU stay	Postoperative day 1
Postoperative acute care unit or intensive care unit length of stay	Postoperative acute care unit or intensive care unit length of stay	30 days postsurgery
Hospital length of stay	hospital length of stay	30 days postsurgery

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: APHP
• Investigators: Study Director: Jacques Duranteau, PhD, Bicetre Hospital; Study Chair: APHP BICETRE, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 30, 2020

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A03365-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No