Clinical trial NCT03469570: Assisted Fluid Management IDE Study
Official title: A Validation of the Assisted Fluid Management Feature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Cardiac/ Non-Thoracic Surgery
Abdominal Surgery
Pelvic Surgery
Major Peripheral Vascular Surgery
Keywords: Non-Cardiac
Non-Thoracic
Fluid Management
Perioperative Goal Directed Therapy
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Effectiveness of the Assisted Fluid Management Feature
timeFrame: 30 Day follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Health University
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System, Greenville Memorial Hospital
state: South Carolina
city: Dallas
country: United States
facility: The University of Texas Southwestern at Clements
state: Texas
Study officials:
affiliation: Edwards Lifesciences
name: Tina Abdelnour, MS, BSN
role: STUDY_DIRECTOR
References:
citation: 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.