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

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ClinicalTrials.gov Identifier: NCT03779373
Recruitment Status : Withdrawn (Change of hospital when the study will be done. We will redo the clinical trial to have the good sponsor for the study.)
First Posted : December 19, 2018
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
APHP
Information provided by (Responsible Party):
Alexandre Joosten, Erasme University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Goal Directed Fluid Therapy Other: Use of a decision support system on the EV1000 monitor (AFM mode) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 30, 2020
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. composite criteria of minor postoperative complications [ Time Frame: 30 days postsurgery ]

    This composite score includes 8 items :

    1. postoperative nausea and vomiting
    2. delirium and confusion
    3. Infection of surgical site
    4. urinary infection
    5. acute kidney injury (KDIGO I & II classiciation)
    6. paralytic ileus
    7. other infection (skin, catheter, unknown etc)
    8. Readmission to the hospital within 30 days postoperative


Secondary Outcome Measures :
  1. Percentage of Time spent during the procedure with a stroke volume variation < 13% [ Time Frame: Postoperative day 1 ]
    Percentage of Time spent during the procedure with a stroke volume variation < 13%

  2. Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2 [ Time Frame: Postoperative day 1 ]
    Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2

  3. composite criteria of major postoperative complications [ Time Frame: 30 days postsurgery ]

    This composite score includes 14 items :

    1. stoma dehiscence
    2. Peritonitis
    3. Sepsis
    4. wound dehiscence
    5. bleeding requiring a redo surgery
    6. pulmonary embolism
    7. pulmonary edema
    8. Pneumonia
    9. acute coronary syndrome
    10. atrial fibrillation
    11. stroke
    12. Dialysis
    13. non scheduled redo surgery
    14. 30days mortality (all causes)

  4. cardiac index over the procedure [ Time Frame: Postoperative day 1 ]
    average cardiac index over the surgery

  5. stroke volume over the procedure [ Time Frame: Postoperative day 1 ]
    average stroke volume over the procedure

  6. stroke volume variation over the procedure [ Time Frame: Postoperative day 1 ]
    average stroke volume variation over the procedure

  7. Total Fluid received during the procedure [ Time Frame: Postoperative day 1 ]
    amount of fluid received during surgery

  8. Net fluid balance [ Time Frame: Postoperative day 1 ]
    Net fluid balance at the end of the ICU stay

  9. Postoperative acute care unit or intensive care unit length of stay [ Time Frame: 30 days postsurgery ]
    Postoperative acute care unit or intensive care unit length of stay

  10. Hospital length of stay [ Time Frame: 30 days postsurgery ]
    hospital length of stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779373


Locations
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France
Joosten Alexandre
Paris, Kremlin Bicetre, France, 94270
Sponsors and Collaborators
Erasme University Hospital
APHP
Investigators
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Study Director: Jacques Duranteau, PhD Bicetre Hospital
Study Chair: APHP BICETRE Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Alexandre Joosten, Principal Investigator, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03779373    
Other Study ID Numbers: 2018-A03365-50
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No