Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
NCT06011187 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- PROCEDURE Routine care
- DEVICE AFM
Study Locations (17)
Paris
- BICETRE — Le Kremlin-Bicêtre
- BEAUJON — Paris
- Insititut Mutualiste Montsouris — Paris
California
- University of California IRVINE — Irvine
- University of California Los Angeles (UCLA) — Los Angeles
PARIS
- HEGP — Paris
- La Pitie Salpetriere — Paris
Other
- Chu Lille — Lille
- Centre hospitalier universitaire de NANCY — Nancy
Brussels Capital
- UZ Brussels — Brussels
Montreal
- CHUM Montreal — Montreal
Dijon
- Chu Dijon — Dijon
France
- ALEXANDRE JOOSTEN, MD PhD — Le Kremlin-Bicêtre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06011187
The ClinicalTrials.gov registry entry for NCT06011187 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Assistance Publique - Hôpitaux de Paris, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Decision Support System appearing as the primary indexed condition, and to 2 interventions — of which Routine care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06011187 reports 17 study locations spanning 12 distinct geographic areas — top geographies include Paris, California, PARIS. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06011187 about?
NCT06011187 is a clinical study titled "Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery". 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 ...
What is the current status of trial NCT06011187?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,000 participants. The study started on 2024-02-01. Estimated completion is 2026-12-30.
What conditions does trial NCT06011187 study?
This clinical trial studies the following conditions: Decision Support System, Outcome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06011187?
The interventions under investigation include: Routine care (PROCEDURE), AFM (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06011187?
This trial is sponsored by Assistance Publique - Hôpitaux de Paris, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06011187 being conducted?
This trial has 17 study locations across California, Brussels Capital, Montreal, Dijon, France. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.