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Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

NCT02978430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-03-13

No results posted yet for this study

Summary

The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

Conditions

  • Major Abdominal Surgery

Interventions

DEVICE

Computer-assisted GDFT

Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

OTHER

Standard of care

Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Belgium

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 NCT02978430 on ClinicalTrials.gov