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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: Recruiting NA study of Decision Support System and Outcome, sponsored by Assistance Publique - Hôpitaux de Paris.
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, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after 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 |
What NCT06011187 shows while recruiting
NCT06011187 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher).
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 lists 17 locations in 12 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06011187's enrollment target sits among peer trials
2,000 52nd of 2000 higher than 1,947 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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