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Assisted Fluid Management IDE Study (AFM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03469570
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

Condition or disease Intervention/treatment Phase
Non-Cardiac/ Non-Thoracic Surgery Abdominal Surgery Pelvic Surgery Major Peripheral Vascular Surgery Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature Not Applicable

Detailed Description:

The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Validation of the Assisted Fluid Management Feature
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : January 25, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Assisted Fluid Management Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of the Assisted Fluid Management Feature: Stroke volume change meeting the clinician-selected fluid strategy [ Time Frame: 30 Day follow-up ]
    Stroke volume change meeting the clinician-selected fluid strategy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be ≥ 18 years of age
  • Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction
  • Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form.

Exclusion Criteria:

  • Are < 18 years of age
  • Emergent or cardiovascular surgical procedure
  • Are pregnant
  • Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study)
  • Refusal of patient or authorized representative to sign consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469570


Locations
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United States, California
Loma Linda Health University
Loma Linda, California, United States, 92354
University of California, Davis
Sacramento, California, United States, 95817
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Stony Brook Medicine
Stony Brook, New York, United States, 11794-8480
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville Health System, Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
United States, Texas
The University of Texas Southwestern at Clements
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Publications:

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03469570    
Other Study ID Numbers: 2017-011
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Edwards Lifesciences:
Non-Cardiac
Non-Thoracic
Fluid Management
Perioperative Goal Directed Therapy