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出境医 / 临床实验 / Impact of an Assisted Fluid Management System on Microvascular Parameters (MicroSupport)

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

Study Description
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 or 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.

Mean arterial pressure will be at least maintained in both groups above 65 mmHg with norepinephrine administration. Vasopressors administration is standardised in both groups (objective is a MAP of > 65 mmHg) and the only difference will be the way fluid boluses are given to the patient (following standard of care (manual protocol) of following the assisted fluid management recommandations)

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)

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 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 Real Time 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 : May 31, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE May 31, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		Microvascular flow index [ Time Frame: Day 0 ]
Comparison of this index between groups during the intraoperative period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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
  • 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)
  • Stroke volume over the procedure [ Time Frame: Postoperative day 1 ]
    average stroke volume over the procedure
  • Cardiac output over the procedure [ Time Frame: Postoperative day 1 ]
    average cardiac output over the surgery
  • Total Fluid received during the procedure [ Time Frame: Postoperative day 1 ]
    amount of fluid received during surgery
  • Net fluid balance [ Time Frame: Postoperative day 1 ]
    Net fluid balance at the end of the surgery
  • Hospital length of stay [ Time Frame: 30 days postsurgery ]
    hospital length of stay
  • 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.
  • 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.
  • 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.
  • minimal value of microvascular flow index [ Time Frame: Day 0 ]
    minimal value of this index during the intraoperative period
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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
  • 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)
  • Stroke volume over the procedure [ Time Frame: Postoperative day 1 ]
    average stroke volume over the procedure
  • Cardiac output over the procedure [ Time Frame: Postoperative day 1 ]
    average cardiac output over the surgery
  • Total Fluid received during the procedure [ Time Frame: Postoperative day 1 ]
    amount of fluid received during surgery
  • Net fluid balance [ Time Frame: Postoperative day 1 ]
    Net fluid balance at the end of the surgery
  • Hospital length of stay [ Time Frame: 30 days postsurgery ]
    hospital length of stay
  • Proportion of perfused vessels [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period
  • Perfused vessel density [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period
  • Heterogeneity index [ Time Frame: Day 0 ]
    Comparison of this index between groups during the intraoperative period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of an Assisted Fluid Management System on Microvascular Parameters
Official Title  ICMJE Impact of a Real Time Clinical Decision Support System to Guide Fluid Administration on Microvascular Parameters in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial
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 or orthopedic surgery.
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.

Mean arterial pressure will be at least maintained in both groups above 65 mmHg with norepinephrine administration. Vasopressors administration is standardised in both groups (objective is a MAP of > 65 mmHg) and the only difference will be the way fluid boluses are given to the patient (following standard of care (manual protocol) of following the assisted fluid management recommandations)

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Monitoring
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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)
    Intervention: Other: Manual application of the GDFT protocol (standard of care)
  • 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)
    Intervention: Device: Use of a decision support system on the EV1000 monitoring (AFM mode)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2020) 		86
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019) 		78
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandre Joosten, MD PhD 0033145216310 alexandre.joosten@aphp.fr
Contact: Jacques Duranteau, MD PhD 0033145216310 jacques.duranteau@aphp.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965702
Other Study ID Numbers  ICMJE APHP191024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre Joosten, MD PhD BICETRE HOSPITAL, APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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