Impact of an Assisted Fluid Management System on Microvascular Parameters

NCT03965702 | Completed

• 1 other identifier: APHP191024
• Study Type: interventional
• Target: 86
• 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 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

Outcome Measures

Primary Outcomes (1)

• Microvascular flow index

  Comparison of this index between groups during the intraoperative period. The image is divided into four quadrants and the predominant type of flow in very small vessels is assessed in each quadrant using an ordinal score (0= no flow; 1 = intermittent flow; 2 = sluggish flow; 3 = normal flow). The overall score, called microvascular flow index, is the sum of each quadrant score divided by the number of quadrants

  Day 0

Secondary Outcomes (11)

• Composite criteria of minor postoperative complications

  30 days postsurgery

• Composite criteria of major postoperative complications

  30 days postsurgery

• Stroke volume over the procedure

  Postoperative day 1

• Cardiac output over the procedure

  Postoperative day 1

• Total Fluid received during 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 Life sciences, Irvine, USA)

Other: Manual application of the GDFT protocol (standard of care)

EV1000 monitoring 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 Life sciences, Irvine, USA)

Device: Use of a decision support system on the EV1000 monitoring (AFM mode)

Interventions

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

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.

EV1000 monitoring with the decision (AFM)

Manual application of the GDFT protocol (standard of care) OTHER

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.

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 arrythmia.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (1)

• Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.

  PMID: 39116013 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexandre Joosten, MD PhD

  BICETRE HOSPITAL, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All microvascular parameters will be analyzed at the end of the study by a blinded physicians (not linked to the study and not author of the future manuscript)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: December 13, 2021
• Primary Completion: July 10, 2022
• Study Completion: August 11, 2022
• Last Updated: August 30, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)