AFM System for Postoperative Recovery in High-Risk Abdominal Surgery (PEFLA Trial)

N/A

Recruiting

Research Sponsored by Assistance Publique - Hôpitaux de Paris

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 30

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate the impact of an AI-based system to guide fluid bolus administration on post-op complications in high-risk surgery patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial description does not specify side effects of the AFM system, potential risks may include complications from incorrect fluid management such as dehydration or fluid overload affecting organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery

Secondary study objectives

Incidence of a composite of postoperative infection rate within 30-day of surgery.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Assisted fluid management systemExperimental Treatment1 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 careActive Control1 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

Do I qualify?Apply below to find out