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Procedure

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 90

Awards & highlights

PEFLA Trial 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.Check my eligibility

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.See study design

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.

PEFLA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Clavien-dindo classification score

Comprehensive complication index (CCI)

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

+5 more

PEFLA 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

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Who is running the clinical trial?

Assistance Publique - Hôpitaux de ParisLead Sponsor

3,144 Previous Clinical Trials

56,879,921 Total Patients Enrolled

ALEXANDRE JOOSTEN, MD PhDStudy DirectorPAUL BROUSSE HOSPITAL

2 Previous Clinical Trials

150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific research being conducted in multiple medical facilities within the city?

"Currently, 16 healthcare establishments are running this clinical trial - many in prominent cities such as Los Angeles, Brussel and Montréal. If you decide to take part, it is best to select the closest location available so that travelling needs can be minimized."

Answered by AI

Is this research initiative currently enrolling participants?

"The information held on clinicaltrials.gov affirms that this experiment is not accepting participants at present. Posting first on September 19th, 2023 and last edited August 21st, 2023, no new candidates are being enrolled in this trial; however, there are 9 other active studies seeking volunteers currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery

2024. "Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011187.