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NCT03965702: MicroSupport

Impact of an Assisted Fluid Management System on Microvascular Parameters

Completed NA Last updated 30 August 2022
What this trial tests

NA trial testing Use of a decision support system on the EV1000 monitoring (AFM mode) in Monitoring in 86 participants. Completed in 11 August 2022.

Timeline
13 December 2021
Primary endpoint
10 July 2022
11 August 2022

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment86
Start date13 December 2021
Primary completion10 July 2022
Estimated completion11 August 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 99, any sex, with Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Life sciences, Irvine, USA) to a group of patients managed using a novel real time clinical decision support system for goal directed fluid therapy (GDFT) guidance on microvascular parameters in patients undergoing major abdominal or orthopedic surgery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial.
    Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, et al · · 2025 · cited 13× · PMID 39116013 · DOI 10.1213/ane.0000000000007097
  2. Decision support guided fluid challenges and stroke volume response during high-risk surgery: a post hoc analysis of a randomized controlled trial.
    Coeckelenbergh S, Rinehart J, Desebbe O, Rogoz N, et al · · 2025 · cited 4× · PMID 39826044 · DOI 10.1007/s10877-025-01261-7

Verify or expand the search:

Other recruiting trials for Monitoring

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03965702.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing