MonitoringMicroSupportNCT03965702
Impact of an Assisted Fluid Management System on Microvascular Parameters
A study testing Use of a decision support system on the EV1000 monitoring (AFM mode) in people with Monitoring, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Monitoring
- What is being tested?
- Use of a decision support system on the EV1000 monitoring (AFM mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 11 Aug 2022
- 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 arrythmia.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Monitoring
- Being tested
- Use of a decision support system on the EV1000 monitoring (AFM mode), Manual application of the GDFT protocol (standard of care)
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 monitoring (AFM mode)Device
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.
Manual application of the GDFT protocol (standard of care)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| EV1000 monitoring | Active comparator | 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) Receives: Other: Manual application of the GDFT protocol (standard of care) |
| EV1000 monitoring with the decision (AFM) | Experimental | 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) Receives: Device: Use of a decision support system on the EV1000 monitoring (AFM mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular flow index
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
Measured: Day 0
Secondary outcomes (11)
Composite criteria of minor postoperative complications
This composite score includes 8 items (1 point for each item present; minimum score is 0 and maximum is 8 points)
- postoperative nausea and vomiting
- delirium and confusion
- Infection of surgical site
- urinary infection
- acute kidney injury (KDIGO I \& II classiciation)
- paralytic ileus
- other infection (skin, catheter, unknown etc)
- Readmission to the hospital within 30 days postoperative
Measured: 30 days postsurgery
Composite criteria of major postoperative complications
This composite score includes 14 items (one point for each item present; minimum score is 0 and maximum is 14 points):
- stoma dehiscence
- Peritonitis
- Sepsis
- wound dehiscence
- bleeding requiring a redo surgery
- pulmonary embolism
- pulmonary edema
- Pneumonia
- acute coronary syndrome
- atrial fibrillation
- stroke
- Dialysis
- non scheduled redo surgery
- 30days mortality (all causes)
Measured: 30 days postsurgery
Stroke volume over the procedure
average stroke volume over the procedure
Measured: Postoperative day 1
Cardiac output over the procedure
average cardiac output over the surgery
Measured: Postoperative day 1
Total Fluid received during the procedure
amount of fluid received during surgery
Measured: Postoperative day 1
Net fluid balance
Net fluid balance at the end of the surgery
Measured: Postoperative day 1
Hospital length of stay
hospital length of stay
Measured: 30 days postsurgery
Proportion of perfused vessels
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.
Measured: Day 0
Perfused vessel density
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.
Measured: Day 0
Heterogeneity index
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.
Measured: Day 0
minimal value of microvascular flow index
minimal value of this index during the intraoperative period
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start13 Dec 2021
- Primary completion10 Jul 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MonitoringStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Joosten, MD PhD, Principal investigator, BICETRE HOSPITAL, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965702
- Sponsor's protocol ID
- APHP191024
- Acronym
- MicroSupport
- Status last verified
- Dec 2021
- First submitted
- 24 May 2019
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.
PubMed 39116013
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03965702
- Acronym / sponsor ID
- MicroSupport / APHP191024
- Conditions
- Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV1000 monitoring | Active comparator | Other: Manual application of the GDFT protocol (standard of care)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) |
| EV1000 monitoring with the decision (AFM) | Experimental | Device: Use of a decision support system on the EV1000 monitoring (AFM mode)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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Minor Patients.
- No french speaking.
- Atrial fibrillation or severe arrythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. Blood pressure wil standardized in both group. | Device | EV1000 monitoring with the decision (AFM) |
| 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. Blood pressure wil standardized in both group. | Other | EV1000 monitoring |
Primary outcome
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
11 secondary outcomes
Composite criteria of minor postoperative complications
Time frame: 30 days postsurgery
Composite criteria of major postoperative complications
Time frame: 30 days postsurgery
Stroke volume over the procedure
Time frame: Postoperative day 1
Cardiac output over the procedure
Time frame: Postoperative day 1
Total Fluid received during the procedure
Time frame: Postoperative day 1
Net fluid balance
Time frame: Postoperative day 1
Hospital length of stay
Time frame: 30 days postsurgery
Proportion of perfused vessels
Time frame: Day 0
Perfused vessel density
Time frame: Day 0
Heterogeneity index
Time frame: Day 0
minimal value of microvascular flow index
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 39116013Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Joosten, MD PhD principal investigator
BICETRE HOSPITAL, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a decision support system on the EV1000 monitoring (AFM mode) in people with Monitoring, run by Assistance Publique - Hôpitaux de Paris 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: finished, as of the sponsor's last update on 30 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microvascular flow index (time frame: Day 0). 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 NCT03965702, which also lists 1 linked publication.
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 30 Aug 2022.