Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of an Assisted Fluid Management System on Microvascular Parameters (MicroSupport)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965702
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Life sciences, Irvine, USA) to a group of patients managed using a novel real time clinical decision support system for goal directed fluid therapy (GDFT) guidance on microvascular parameters in patients undergoing major abdominal and orthopedic surgery.

Condition or disease Intervention/treatment Phase
Monitoring Device: Use of a decision support system on the EV1000 monitoring (AFM mode) Other: Manual application of the GDFT protocol (standard of care) Not Applicable

Detailed Description:

Many trials have indicated that GDFT strategies may benefit high-risk surgical patients but these strategies are infrequently implemented on a day to day basis. 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 novel real time 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 in a preload independent state (defined as a SVV < 13%) with a reduced total amount of fluid administered without any difference in postoperative complications.

Another recent study demonstrated that during abdominal surgery, microvascular perfusion is impaired during preload dependence (SVV >13%) and recovers after fluid administration (preload independent state)

Therefore the goal of this bicentric 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 Microvascular flow index.

We assume that this novel clinical decision support system will allow patients to have less alterations of their microvascular parameters than patients managed under standard of care (GDFT but without the assisted fluid management mode)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: All microvascular parameters will be analyzed at the end of the study by a blinded physicians (not linked to the study and not author of the future manuscript)
Primary Purpose: Other
Official Title: Impact of a Clinical Decision Support System to Guide Fluid Administration on Microvascular Parameters in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial
Estimated Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 15, 2021

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 Life sciences, Irvine, USA)
Other: Manual application of the GDFT protocol (standard of care)
Manual application of a GDFT protocol to guide fluid administration. Measurement of all microvascumlar parameters in blinded way.

Experimental: EV1000 monitoring 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 Life sciences, Irvine, USA)
Device: Use of a decision support system on the EV1000 monitoring (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 decision support system for fluid administration called AFM (assisted fluid management) Measurement of all microvascumlar parameters in blinded way.




Primary Outcome Measures :
  1. Microvascular flow index [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period. The image is divided into four quadrants and the predominant type of flow in very small vessels is assessed in each quadrant using an ordinal score (0= no flow; 1 = intermittent flow; 2 = sluggish flow; 3 = normal flow). The overall score, called microvascular flow index, is the sum of each quadrant score divided by the number of quadrants


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

    This composite score includes 8 items (1 point for each item present; minimum score is 0 and maximum is 8 points)

    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

  2. Composite criteria of major postoperative complications [ Time Frame: 30 days postsurgery ]

    This composite score includes 14 items (one point for each item present; minimum score is 0 and maximum is 14 points):

    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)

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

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

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

  6. Net fluid balance [ Time Frame: Postoperative day 1 ]
    Net fluid balance at the end of the surgery

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

  8. Proportion of perfused vessels [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period. This is calculated as follow: 100 x (total number of vessels - [no flow+intermittent flow]/total number of vessels.

  9. Perfused vessel density [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period. This is calculated automatically by dividing the area of perfused vessels by the total area of interest using the Automated Vascular Analysis software.

  10. Heterogeneity index [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period. This is calculated as follows: (highest site microvascular flow index-lowest site microvascular flow index) divided by the mean of the microvascular flow index of all sublingual sites.

  11. minimal value of microvascular flow index [ Time Frame: Day 0 ]
    minimal value of this index during the intraoperative period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 arrythmia.

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): NCT03965702


Contacts
Layout table for location contacts
Contact: Alexandre Joosten, MD PhD 0033145216310 alexandre.joosten@aphp.fr
Contact: Jacques Duranteau, MD PhD 0033145216310 jacques.duranteau@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Alexandre Joosten, MD PhD BICETRE HOSPITAL, APHP

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03965702     History of Changes
Other Study ID Numbers: APHP190003
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No