AFM System for Postoperative Recovery in High-Risk Abdominal Surgery

(PEFLA Trial)

Recruiting at 18 trial locations

Overseen By Jacques DURANTEAU, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Assistance Publique - Hôpitaux de Paris

Disqualifiers: Cardiac arrhythmias, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI-based system, Assisted Fluid Management (AFM), to improve fluid management during high-risk abdominal surgeries. The goal is to determine if this system can reduce major complications after surgery by guiding doctors in administering fluids more precisely. Patients with conditions such as heart disease, kidney problems, or diabetes who are scheduled for elective high-risk abdominal surgery may be suitable candidates. The trial compares the effects of using the AFM system against standard care methods. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance surgical outcomes for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What prior data suggests that the AFM system is safe for postoperative recovery in high-risk abdominal surgery?

Research has shown that the Assisted Fluid Management (AFM) system is a new tool to help doctors administer the right amount of fluid to patients undergoing high-risk surgery. This system uses artificial intelligence to suggest when patients might need more fluids and monitors their physiological responses.

No large studies have yet confirmed the safety of the AFM system in humans. However, this trial is labeled as "Not Applicable" for its phase, indicating a focus on testing the system's effectiveness rather than its safety. This suggests that safety risks are considered low. The system is designed to assist doctors, not replace them, which may help reduce potential risks.

Prospective participants should discuss any safety concerns with the trial coordinators or their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AFM system for postoperative recovery in high-risk abdominal surgery because it introduces a methodically guided approach to fluid management. Unlike the routine care, which relies on general protocols, the AFM system offers personalized fluid administration based on specific patient needs, thereby potentially enhancing recovery outcomes. This system aims to maintain mean arterial pressure within an optimal range more precisely, reducing complications and improving patient stability after surgery.

What evidence suggests that the AFM system is effective for postoperative recovery in high-risk abdominal surgery?

This trial will compare the Assisted Fluid Management (AFM) system with routine care in postoperative recovery for high-risk abdominal surgery. Research has shown that the AFM system predicts a patient's fluid response more accurately than doctors. It aims to reduce instances where the heart requires additional fluid and to improve overall blood flow. The AFM system uses artificial intelligence to assist doctors in deciding when to administer fluids during surgery, potentially preventing major complications afterward. However, no large studies have yet demonstrated its impact on patient outcomes compared to usual care. While early findings are promising, further research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

ALEXANDRE JOOSTEN, MD PhD

Principal Investigator

PAUL BROUSSE HOSPITAL

Are You a Good Fit for This Trial?

This trial is for adults (18+) undergoing high-risk abdominal surgery who have conditions like stroke, diabetes, liver cirrhosis, heart disease, or obesity. They must be able to give informed consent and not be in another conflicting trial or pregnant. Those with cardiac arrhythmias are excluded.

Inclusion Criteria

I am an adult scheduled for a major abdominal surgery.

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), chronic heart failure (New York Heart Association Functional Classification ≥ 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

Exclusion Criteria

Pregnant patients

No affiliation with the French health care system

I have a heart rhythm problem known as atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Participants receive routine care with fluid therapy done as usual care

Varies by cluster

Intervention Phase

Fluid bolus administration guided by the AFM system

Varies by cluster

Follow-up

Participants are monitored for major postoperative complications within 30 days after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AFM
• Routine care

Trial Overview The study tests an 'Assisted Fluid Management' (AFM) system against routine care in managing fluid therapy during high-risk abdominal surgeries. The AFM uses AI to suggest fluid boluses and assess ongoing needs to improve postoperative outcomes.

How Is the Trial Designed?

Group I: Assisted fluid management system Experimental Treatment 1 Intervention

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

Group II: Routine care Active Control 1 Intervention

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

AFM is already approved in European Union, United States for the following indications:

Approved in European Union as Acumen Assisted Fluid Management for:

• High-risk abdominal surgery

Approved in United States as Acumen Assisted Fluid Management for:

• Moderate- to high-risk noncardiac surgery

Who Is Running the Clinical Trial?

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

Trials

3,369

Recruited

57,400,000+

Published Research Related to This Trial

In a study of 32 patients undergoing elective colonic surgery, a 'restrictive' fluid regimen (median 1640 ml) significantly improved pulmonary function and reduced postoperative hypoxaemia compared to a 'liberal' regimen (median 5050 ml).

Despite the benefits in pulmonary function, the 'restrictive' fluid group showed a trend towards increased morbidity, suggesting that future research should explore individualized fluid management strategies rather than fixed amounts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liberal or restrictive fluid administration in fast-track colonic surgery: a randomized, double-blind study. Holte, K., Foss, NB., Andersen, J., et al.[2022]

In a study of 144 acute care surgery patients in the surgical ICU, achieving a negative fluid balance (FB-) by day 5 was linked to a nearly 70% reduction in the risk of mortality, indicating its potential importance in postoperative care.

Achieving a negative fluid balance as early as day 1 also significantly reduced the risk of overall and infectious complications, suggesting that careful fluid management can improve outcomes in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of positive fluid balance on critically ill surgical patients: a prospective observational study. Barmparas, G., Liou, D., Lee, D., et al.[2022]

In a study of 160 patients undergoing major elective abdominal surgery, those receiving balanced colloids as part of a closed-loop goal-directed fluid therapy experienced significantly fewer postoperative complications compared to those receiving balanced crystalloids.

The colloid group also had a lower Post-Operative Morbidity Survey score and required less total fluid volume during surgery, suggesting that using colloids may lead to better outcomes by minimizing fluid overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crystalloid versus Colloid for Intraoperative Goal-directed Fluid Therapy Using a Closed-loop System: A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgery. Joosten, A., Delaporte, A., Ickx, B., et al.[2018]

The Assisted Fluid Management (AFM) system significantly improved the time patients spent with a stroke volume variation (SVV) below 13% during major abdominal surgery, compared to a manual fluid management approach, with a median of 92% versus 76%.

Patients managed with the AFM system received less total fluid during surgery (1775 ml) compared to the control group (2350 ml), while the incidence of postoperative complications remained similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. Joosten, A., Hafiane, R., Pustetto, M., et al.[2020]

In a study involving 330 adults undergoing noncardiac surgery, fluid management software significantly improved the effectiveness of fluid boluses, achieving a 66% success rate in increasing stroke volume (SV) compared to a 30% reference rate for standard practices.

Boluses recommended by the software resulted in a greater average increase in SV (14.2%) compared to clinician-initiated boluses (8.3%), suggesting that automated fluid management can enhance intraoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Maheshwari, K., Malhotra, G., Bao, X., et al.[2021]

Effective fluid management is essential for enhanced recovery after surgery, aiming to keep patients at a normal fluid balance (euvolemic) before surgery and to maintain proper blood volume during the operation.

Post-surgery, patients should only receive intravenous fluids if absolutely necessary, as they can typically resume oral fluid intake once they are stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery: Intraoperative Fluid Management Strategies. Simmons, JW., Dobyns, JB., Paiste, J.[2018]

In a study of 3650 patients who underwent major abdominal surgery, perioperative positive fluid balance was not linked to an increased risk of unplanned readmission within 30 days after surgery.

However, longer surgery times and higher total relative value unit scores were associated with a higher likelihood of unplanned readmission, indicating that factors related to the complexity and duration of the surgery may be more critical in predicting postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Perioperative Fluid Balance and 30-Day Unplanned Readmission After Major Abdominal Surgery. Oh, TK., Oh, AY., Hwang, JW.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06011187?cond=Acute%20flaccid%20myelitis%20OR%20%22AFM%22&aggFilters=status:not%20rec&viewType=Table&rank=1

NCT06011187 | Assisted Fluid Management (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 ...

2. uclahealth.org uclahealth.org/clinical-trials/assisted-fluid-management-afm-system-and-postoperative

Assisted Fluid Management (AFM) System and ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40529718/

Investigating the effectiveness of an intraoperative decision ... AFM reportedly predicts fluid responsiveness better than clinicians, decreases preload-dependent states, and improves both macro- and microcirculatory variables ...

4. ctv.veeva.com ctv.veeva.com/study/assisted-fluid-management-afm-system-and-postoperative-outcome-after-high-risk-abdominal-surgery

Assisted Fluid Management (AFM) System and Postoperative ... 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 ...

5. ucihealth.org ucihealth.org/clinical-trials/ccr-24-136

Personalized fluid administration using an assisted ... There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome. We therefore aim to conduct ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772609625000450

Investigating the effectiveness of an intraoperative decision ... This trial is powered to provide evidence on whether implementing AFM is effective in reducing postoperative complications in high-risk patients after high- ...

7. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06011187

Assisted Fluid Management (AFM) System and ... 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 ...