AFM System for Postoperative Recovery in High-Risk Abdominal Surgery

(PEFLA Trial)

Recruiting at 15 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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment AFM System for Postoperative Recovery in High-Risk Abdominal Surgery?

Research shows that using the Assisted Fluid Management (AFM) system during major abdominal surgery helps guide fluid administration more effectively, which can optimize patient outcomes by reducing complications related to fluid imbalance. ^{1 2 3 4 5}

How does the AFM system treatment differ from other treatments for postoperative recovery in high-risk abdominal surgery?

The AFM system is unique because it uses real-time software guidance to optimize fluid administration during surgery, ensuring the right amount and timing of fluids, which can be challenging with manual methods. This approach aims to improve recovery by reducing complications associated with both excessive and inadequate fluid administration. ^{1 4 5 6 7}

Research Team

ALEXANDRE JOOSTEN, MD PhD

Principal Investigator

PAUL BROUSSE HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. [2021]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Association Between Perioperative Fluid Balance and 30-Day Unplanned Readmission After Major Abdominal Surgery. [2020]

4. Netherlands 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Liberal or restrictive fluid administration in fast-track colonic surgery: a randomized, double-blind study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of positive fluid balance on critically ill surgical patients: a prospective observational study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery: Intraoperative Fluid Management Strategies. [2018]