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NCT06011187 · ClinicalTrials.gov registry record · NA
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
A NA study of Decision Support System and Outcome, sponsored by Assistance Publique - Hôpitaux de Paris.
- Recruiting
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
- 17
- Study locations
NCT06011187 is a NA study of Decision Support System and Outcome that is actively recruiting participants, run by Assistance Publique - Hôpitaux de Paris. The registered enrollment target is 2,000 participants. The trial reports 17 study locations across 12 states.
The verdict
NCT06011187, a NA study of Decision Support System and Outcome, is actively recruiting participants, sponsored by Assistance Publique - Hôpitaux de Paris.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
- 17
- Study locations
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?
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, categorized as NA. 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.
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.
NCT06011187 reports 17 study locations spanning 12 distinct geographic areas - top geographies include Paris, California, PARIS.
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.
What interventions are being tested in trial NCT06011187?
The interventions under investigation include: Routine care (PROCEDURE), AFM (DEVICE).
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.
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.
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