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Goal Directed Fluid TherapyAFMNCT03779373

Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery

A study testing Use of a decision support system on the EV1000 monitor (AFM mode) in people with Goal Directed Fluid Therapy, run by Erasme University Hospital at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Goal Directed Fluid Therapy
What is being tested?
Use of a decision support system on the EV1000 monitor (AFM mode)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
1 Apr 2019to 30 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Joosten Alexandre

    Paris, Kremlin Bicetre, 94270

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Use of a decision support system on the EV1000 monitor (AFM mode)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of a decision support system on the EV1000 monitor (AFM mode)Other

    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)

Study groups in NCT03779373
Study groupRoleWhat they receive
EV1000 monitoringActive comparatorThis 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)
Receives: Other: Use of a decision support system on the EV1000 monitor (AFM mode)
EV1000 monioring with the decision (AFM)ExperimentalThis 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)
Receives: Other: Use of a decision support system on the EV1000 monitor (AFM mode)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite criteria of minor postoperative complications

    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

    Measured: 30 days postsurgery

Secondary outcomes (10)

  1. 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%

    Measured: Postoperative day 1

  2. 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

    Measured: Postoperative day 1

  3. composite criteria of major postoperative complications

    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)

    Measured: 30 days postsurgery

  4. cardiac index over the procedure

    average cardiac index over the surgery

    Measured: Postoperative day 1

  5. stroke volume over the procedure

    average stroke volume over the procedure

    Measured: Postoperative day 1

  6. stroke volume variation over the procedure

    average stroke volume variation over the procedure

    Measured: Postoperative day 1

  7. Total Fluid received during the procedure

    amount of fluid received during surgery

    Measured: Postoperative day 1

  8. Net fluid balance

    Net fluid balance at the end of the ICU stay

    Measured: Postoperative day 1

  9. Postoperative acute care unit or intensive care unit length of stay

    Postoperative acute care unit or intensive care unit length of stay

    Measured: 30 days postsurgery

  10. Hospital length of stay

    hospital length of stay

    Measured: 30 days postsurgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start1 Apr 2019 (estimated)
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion30 Jul 2020 (estimated)

Why it stopped: Change of hospital when the study will be done. We will redo the clinical trial to have the good sponsor for the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03779373
Sponsor's protocol ID
2018-A03365-50
Acronym
AFM
Status last verified
May 2019
First submitted
16 Dec 2018
Last updated
14 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Use of a decision support system on the EV1000 monitor (AFM mode) in people with Goal Directed Fluid Therapy, run by Erasme University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite criteria of minor postoperative complications (time frame: 30 days postsurgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03779373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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