- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965702
Impact of an Assisted Fluid Management System on Microvascular Parameters (MicroSupport)
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Le Kremlin Bicêtre, France, 94270
- Hôpital du Kremlin Bicetre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 arrythmia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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 Life sciences, Irvine, USA)
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Manual application of a GDFT protocol to guide fluid administration.
Measurement of all microvascumlar parameters in blinded way.
Blood pressure wil standardized in both group.
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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)
|
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.
Blood pressure wil standardized in both group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Day 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Fluid received during the procedure
Time Frame: Postoperative day 1
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amount of fluid received during surgery
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Postoperative day 1
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Hospital length of stay
Time Frame: 30 days postsurgery
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hospital length of stay
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30 days postsurgery
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Composite criteria of minor postoperative complications
Time Frame: 30 days postsurgery
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This composite score includes 8 items (1 point for each item present; minimum score is 0 and maximum is 8 points)
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30 days postsurgery
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Composite criteria of major postoperative complications
Time Frame: 30 days postsurgery
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This composite score includes 14 items (one point for each item present; minimum score is 0 and maximum is 14 points):
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30 days postsurgery
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Stroke volume over the procedure
Time Frame: Postoperative day 1
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average stroke volume over the procedure
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Postoperative day 1
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Cardiac output over the procedure
Time Frame: Postoperative day 1
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average cardiac output over the surgery
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Postoperative day 1
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Net fluid balance
Time Frame: Postoperative day 1
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Net fluid balance at the end of the surgery
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Postoperative day 1
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Proportion of perfused vessels
Time Frame: Day 0
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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.
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Day 0
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Perfused vessel density
Time Frame: Day 0
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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.
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Day 0
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Heterogeneity index
Time Frame: Day 0
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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.
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Day 0
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minimal value of microvascular flow index
Time Frame: Day 0
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minimal value of this index during the intraoperative period
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Day 0
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Collaborators and Investigators
Investigators
- Principal Investigator: Alexandre Joosten, MD PhD, BICETRE HOSPITAL, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP191024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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