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Impact of an Assisted Fluid Management System on Microvascular Parameters

NCT03965702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-08-30

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 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.

Conditions

  • Monitoring

Interventions

DEVICE

Use of a decision support system on the EV1000 monitoring (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 decision support system for fluid administration called AFM (assisted fluid management) Measurement of all microvascumlar parameters in blinded way. Blood pressure wil standardized in both group.

OTHER

Manual application of the GDFT protocol (standard of care)

Manual application of a GDFT protocol to guide fluid administration. Measurement of all microvascumlar parameters in blinded way. Blood pressure wil standardized in both group.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexandre Joosten, MD PhD · BICETRE HOSPITAL, APHP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2022-07-10
Completion
2022-08-11

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 NCT03965702 on ClinicalTrials.gov