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Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery

NCT03779373 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-14

No results posted yet for this study

Summary

This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.

Conditions

  • Goal Directed Fluid Therapy

Interventions

OTHER

Use of a decision support system on the EV1000 monitor (AFM mode)

The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)

Sponsors & Collaborators

  • APHP

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jacques Duranteau, PhD · Bicetre Hospital

  • APHP BICETRE · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-07-01
Completion
2020-07-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779373 on ClinicalTrials.gov