NCT03469570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

November 8, 2024

Completed
Last Updated

November 8, 2024

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

March 12, 2018

Results QC Date

October 16, 2024

Last Update Submit

October 16, 2024

Conditions

Non-Cardiac/ Non-Thoracic SurgeryAbdominal SurgeryPelvic SurgeryMajor Peripheral Vascular Surgery

Keywords

Non-CardiacNon-ThoracicFluid ManagementPerioperative Goal Directed Therapy

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the Assisted Fluid Management Feature

    Stroke volume change meeting the clinician-selected fluid strategy

    30 Day follow-up

Study Arms (1)

Assisted Fluid Management

EXPERIMENTAL

Subjects enrolled in the validation study will have their fluid management decisions guided by the Acumen™ Assisted Fluid Management Feature. The Principal Investigator will accept or decline fluid recommendations.

Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

Interventions

EV1000 Clinical Platform with Assisted Fluid Management (AFM) FeatureDEVICE

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

Assisted Fluid Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Loma Linda Health University

Loma Linda, California, 92354, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794-8480, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Health System, Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

The University of Texas Southwestern at Clements

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

    PMID: 18582931BACKGROUND

MeSH Terms

Interventions

Microscopy, Atomic Force

Intervention Hierarchy (Ancestors)

Microscopy, Scanning ProbeMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Edwards Critical Care Clinical Affairs
Organization
Edwards Lifesciences
afmidestudy@edwards.com
(949) 250-7169

Study Officials

  • Tina Abdelnour, MS, BSN

    Edwards Lifesciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

April 19, 2018

Primary Completion

December 21, 2018

Study Completion

January 25, 2019

Last Updated

November 8, 2024

Results First Posted

November 8, 2024

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(10)