Study Stopped
Study never commenced, and is now closed.
Performance of Non-Invasive Monitors During ANH
The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution
1 other identifier
observational
N/A
1 country
1
Brief Summary
The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedApril 27, 2022
April 1, 2022
1 year
March 11, 2014
April 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cardiac output
Metrics: Cardiac output stroke volume Stroke volume: variation
Baseline (Supine) Volume Replaced (S/P ANH)
Eligibility Criteria
Patients scheduled for elective procedures requiring normovolemic hemodilution
You may qualify if:
- Those surgical procedures where ANH is included in the surgical plan and consent is obtained
You may not qualify if:
- Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001).
- Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler.
- Ascites.
- BMI \>35
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Health System
Sacramento, California, 95832, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2014
First Posted
July 2, 2014
Study Start
November 1, 2022
Primary Completion
November 1, 2023
Study Completion
November 1, 2024
Last Updated
April 27, 2022
Record last verified: 2022-04