Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery

NCT03779373 | Withdrawn

• 1 other identifier: 2018-A03365-50
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• composite criteria of minor postoperative complications

  This composite score includes 8 items : 1. postoperative nausea and vomiting 2. delirium and confusion 3. Infection of surgical site 4. urinary infection 5. acute kidney injury (KDIGO I \& II classiciation) 6. paralytic ileus 7. other infection (skin, catheter, unknown etc) 8. Readmission to the hospital within 30 days postoperative

  30 days postsurgery

Secondary Outcomes (10)

• Percentage of Time spent during the procedure with a stroke volume variation < 13%

  Postoperative day 1

• Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2

  Postoperative day 1

• composite criteria of major postoperative complications

  30 days postsurgery

• cardiac index over the procedure

  Postoperative day 1

• stroke volume over the procedure

  Postoperative day 1

Study Arms (2)

EV1000 monitoring

ACTIVE COMPARATOR

This group of patients will receive fluid administration during surgery based on a manual GDFT protocol actually in place in the department using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)

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

EV1000 monioring with the decision (AFM)

EXPERIMENTAL

This group of patients will receive fluid administration during surgery based on a novel clinical decision support system for GDFT guidance using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)

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

Interventions

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

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)

EV1000 monioring with the decision (AFM); EV1000 monitoring

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients in the operating room scheduled for a major abdominal \& orthopedic surgery requiring a cardiac output monitoring (EV1000).
• Written informed consent received before surgery.

You may not qualify if:

• Minor Patients.
• No french speaking.
• Atrial fibrillation or severe arythmia.

Sponsors & Collaborators

• Erasme University Hospital: lead
• APHP: collaborator

Study Sites (1)

Joosten Alexandre

Paris, Kremlin Bicetre, 94270, France

Location

Study Officials

• Jacques Duranteau, PhD

  Bicetre Hospital

  STUDY DIRECTOR

• APHP BICETRE

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: April 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 30, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)