Decision Support SystemPEFLANCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
A study testing Routine care and AFM in people with Decision Support System and Outcome, run by Assistance Publique - Hôpitaux de Paris at 17 sites in 5 countries.
Trial summary
Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" 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 that have been correlated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Support System, Outcome
- What is being tested?
- Routine care and AFM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,007 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 1 Feb 2024to 11 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient (aged 18 years or older) admitted to the operating room for an elective high-risk abdominal surgery (both open and laparoscopically assisted).
- Patients must fulfill at least one of the following high-risk criteria:
- American Society of Anesthesiologists physical status > 2
- classification exercise tolerance < 4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/ American Heart Association
- renal impairment (serum creatinine ≥1.3mg/dL or >115 mmol/l or estimated glomerular filtration rate < 90 mL/min/1.73 m2 within the last 6 months) or renal replacement therapy
- coronary artery disease (any stage)
Show all 16Show fewer
- chronic heart failure (New York Heart Association Functional Classifcation ≥ II)
- valvular heart disease (moderate or severe);
- history of stroke
- peripheral arterial occlusive disease (any stage)
- chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
- diabetes mellitus requiring oral hypoglycemic agent or insulin; immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids)
- liver cirrhosis (any Child-Pugh class)
- -- body mass index ≥30 kg/m2
- current smoking or 15 pack-year history of smoking
- All participants must receive clear study information and give signed informed consent
Who cannot join
- Patients with preoperative cardiac arrhythmias (atrial fibrillation) as the monitoring devices are not accurate under cardiac arrhythmias.
- No affiliation with the French health care system
- Patients participating in another randomized controlled trial with the same clinical endpoint, or interventions possibly compromising the primary outcome.
- Pregnant patients
- Patient on AME (state medical aid) (unless exemption from affiliation)
- Patients guardianship/legal protection/curatorship
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
France12 sites
Chu Dijon
Dijon, Dijon
Chu Grenoble Alpes
Grenoble, Grenoble
ALEXANDRE JOOSTEN, MD PhD
Le Kremlin-Bicêtre, France, 94200
BICETRE
Le Kremlin-Bicêtre, Paris
Centre chirurgical Marie Lannelongue
Le Plessis-Robinson, Haut de Seine
Chu Lille
Lille
Centre hospitalier universitaire de NANCY
Nancy
BEAUJON
Paris, Paris
HEGP
Paris, PARIS
Insititut Mutualiste Montsouris
Paris, Paris
La Pitie Salpetriere
Paris, PARIS
Chu Toulouse
Toulouse, Toulouse
United States2 sites
University of California IRVINE
Irvine, California, 92868
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg
About this study
Official title: "Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery: A Multicenter Stepped-wedge, Cluster-randomized Clinical Trial
Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" 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 that have been correlated with poor patient outcomes.
Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements.
To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.
Read the detailed description
Many trials have indicated that goal-directed fluid therapy (GDFT) strategies or more recently "personalized fluid therapy" 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 that have been correlated with poor patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation. Hemodynamic 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 decision support system, "Assisted Fluid Management" (AFM), has been developed to help ease some of the work 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 artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements.
This system was recently implemented in a before-and-after study in a Belgian academic hospital, where the authors reported that the implementation of this AFM software system allowed a better adherence to the GDFT algorithm. However, as this was a pilot study with a small number of patients, the study was not powered to demonstrate a beneficial effect on the incidence of postoperative complications. More recently, a group from the Cleveland Clinic demonstrated that using AFM system resulted in more boluses being effective when compared to the administration of boluses without AFM support.
There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome. We therefore aim to conduct a multicenter stepped-wedge, cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare a GDFT strategy guided by the AFM system with usual care.
A stepped wedge, cluster-randomized trial approach was chosen in which clusters will be randomized to commence the intervention at different times following an initial control period in which outcomes will be measured for usual care.
So, each center (cluster) began in the control phase and transitioned to the intervention phase at a randomly assigned time (wedge). The order in which each center will move from control to intervention phase will be randomly allocated by a computer algorithm performed by the study statistician.
We selected cluster randomization rather than randomization of individual patients because the control group could be very different among centers (from GDFT strategy using a flow monitoring to GDFT with a written protocol to no clear strategy (use of an arterial line only without any advanced monitoring). Interestingly, this approach also decreases the Hawthorne effect which has been shown to decrease the incidence rate of the primary outcome in recent randomized trials because clinicians know that their patients are included in a research protocol.
- Conditions
- Decision Support System, Outcome
- Being tested
- Routine care, AFM
- Keywords
- hemodynamic, fluid administration, postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careProcedure or surgery
Fluid administration will be given per routine care MAP between 65 - 70 mmHg
AFMDevice
AFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Routine care | Active comparator | During the pre-implementation period, fluid therapy will be done as routine care.
Mean arterial pressure (MAP) will be maintained between 65-70 mmHg per standard of care Receives: Procedure: Routine care |
| Assisted fluid management system | Experimental | In the post-implementation period, fluid bolus administration will be guided by the AFM recommandation.
MAP will be maintained between 65-70 mmHg per standard of care Receives: Device: AFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery
It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after surgery
Measured: Postoperative day 30
Secondary outcomes (8)
Incidence of each of the individual components of the composite primary outcome within 30 days after surgery
Measured: Postoperative day 30
Incidence of the composite primary outcome within 7 days after surgery
Measured: Postoperative day 7
Incidence of a composite of postoperative infection rate within 30-day of surgery.
This is defined as one or more of the following infections: surgical site infection, organ space surgical-site infection, urinary tract infection, laboratory-confirmed blood stream infection or infection, source uncertain (this is defined as an infection which could be more than one of the above but it is unclear which)
Measured: Postoperative day 30
Clavien-dindo classification score
Measured: Postoperative day 30
Comprehensive complication index (CCI)
Measured: Postoperative day 30
Length of stay in the hospital
Measured: Postoperative day 30
Incidence of unplanned hospital re-admission within 30 days after surgery
Measured: Postoperative day 30
Mortality rate at 90 days after surgery.
Measured: Postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Feb 2024
- Primary completion15 Jan 2026
- Study completion11 Mar 2026
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 Decision Support SystemStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,007 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, Study director, PAUL BROUSSE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011187
- Sponsor's protocol ID
- APHP220817
- Acronym
- PEFLA
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Coeckelenbergh S, Delaporte A, Rousseleau D, De Montblanc J, Roullet S, Ramadan J, Cholley B, Sitbon A, Weiss E, Kassab MC, Diop S, Manzi E, Pustetto M, Porta Bonette G, Guinot PG, Guerci P, Vanhonacker D, Carrier FM, Alexander B, Rinehart J, Boldt D, Grogan T, Cannesson M, Duranteau J, Grimaldi L, Pereira B, Joosten A. Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial. BJA Open. 2025 Jun 5;14:100421. doi: 10.1016/j.bjao.2025.100421. eCollection 2025 Jun.
PubMed 40529718
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery: A Multicenter Stepped-wedge, Cluster-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06011187
- Acronym / sponsor ID
- PEFLA / APHP220817
- Conditions
- Decision Support System, Outcome
- Keywords
- hemodynamic, fluid administration, postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 25 Aug 2023 (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.
Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" 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 that have been correlated with poor patient outcomes.
Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements.
To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.
Detailed description
Many trials have indicated that goal-directed fluid therapy (GDFT) strategies or more recently "personalized fluid therapy" 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 that have been correlated with poor patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation. Hemodynamic 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 decision support system, "Assisted Fluid Management" (AFM), has been developed to help ease some of the work 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 artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements.
This system was recently implemented in a before-and-after study in a Belgian academic hospital, where the authors reported that the implementation of this AFM software system allowed a better adherence to the GDFT algorithm. However, as this was a pilot study with a small number of patients, the study was not powered to demonstrate a beneficial effect on the incidence of postoperative complications. More recently, a group from the Cleveland Clinic demonstrated that using AFM system resulted in more boluses being effective when compared to the administration of boluses without AFM support.
There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome. We therefore aim to conduct a multicenter stepped-wedge, cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare a GDFT strategy guided by the AFM system with usual care.
A stepped wedge, cluster-randomized trial approach was chosen in which clusters will be randomized to commence the intervention at different times following an initial control period in which outcomes will be measured for usual care.
So, each center (cluster) began in the control phase and transitioned to the intervention phase at a randomly assigned time (wedge). The order in which each center will move from control to intervention phase will be randomly allocated by a computer algorithm performed by the study statistician.
We selected cluster randomization rather than randomization of individual patients because the control group could be very different among centers (from GDFT strategy using a flow monitoring to GDFT with a written protocol to no clear strategy (use of an arterial line only without any advanced monitoring). Interestingly, this approach also decreases the Hawthorne effect which has been shown to decrease the incidence rate of the primary outcome in recent randomized trials because clinicians know that their patients are included in a research protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Routine care | Active comparator | Procedure: Routine careDuring the pre-implementation period, fluid therapy will be done as routine care. Mean arterial pressure (MAP) will be maintained between 65-70 mmHg per standard of care |
| Assisted fluid management system | Experimental | Device: AFMIn the post-implementation period, fluid bolus administration will be guided by the AFM recommandation. MAP will be maintained between 65-70 mmHg per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Any adult patient (aged 18 years or older) admitted to the operating room for an elective high-risk abdominal surgery (both open and laparoscopically assisted).
- Patients must fulfill at least one of the following high-risk criteria:
- American Society of Anesthesiologists physical status > 2
- classification exercise tolerance < 4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/ American Heart Association
- renal impairment (serum creatinine ≥1.3mg/dL or >115 mmol/l or estimated glomerular filtration rate < 90 mL/min/1.73 m2 within the last 6 months) or renal replacement therapy
Key exclusion criteria (6 listed)
- Patients with preoperative cardiac arrhythmias (atrial fibrillation) as the monitoring devices are not accurate under cardiac arrhythmias.
- No affiliation with the French health care system
- Patients participating in another randomized controlled trial with the same clinical endpoint, or interventions possibly compromising the primary outcome.
- Pregnant patients
- Patient on AME (state medical aid) (unless exemption from affiliation)
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 |
|---|---|---|
| Routine careFluid administration will be given per routine care MAP between 65 - 70 mmHg | Procedure or surgery | Routine care |
| AFMAFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg | Device | Assisted fluid management system |
Primary outcome
Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery
Time frame: Postoperative day 30
It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after surgery
8 secondary outcomes
Incidence of each of the individual components of the composite primary outcome within 30 days after surgery
Time frame: Postoperative day 30
Incidence of the composite primary outcome within 7 days after surgery
Time frame: Postoperative day 7
Incidence of a composite of postoperative infection rate within 30-day of surgery.
Time frame: Postoperative day 30
Clavien-dindo classification score
Time frame: Postoperative day 30
Comprehensive complication index (CCI)
Time frame: Postoperative day 30
Length of stay in the hospital
Time frame: Postoperative day 30
Incidence of unplanned hospital re-admission within 30 days after surgery
Time frame: Postoperative day 30
Mortality rate at 90 days after surgery.
Time frame: Postoperative day 90
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 29 May 2026.
- Derived from this study: PubMed 40529718Coeckelenbergh S, Delaporte A, Rousseleau D, De Montblanc J, Roullet S, Ramadan J, Cholley B, Sitbon A, Weiss E, Kassab MC, Diop S, Manzi E, Pustetto M, Porta Bonette G, Guinot PG, Guerci P, Vanhonacker D, Carrier FM, Alexander B, Rinehart J, Boldt D, Grogan T, Cannesson M, Duranteau J, Grimaldi L, Pereira B, Joosten A. Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial. BJA Open. 2025 Jun 5;14:100421. doi: 10.1016/j.bjao.2025.100421. eCollection 2025 Jun.
- Individual participant dataSharing planned: Undecided
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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 study director
PAUL BROUSSE HOSPITAL
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care and AFM in people with Decision Support System and Outcome, run by Assistance Publique - Hôpitaux de Paris at 17 sites in 5 countries.
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 16 inclusion and 6 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, United States, Belgium, Canada, Germany. 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?
Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery (time frame: Postoperative day 30). 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 NCT06011187, 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 29 May 2026.