BaselineNCT02179827
Performance of Non-Invasive Monitors During ANH
An observational study of Baseline and Hemodilution, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Baseline, Hemodilution
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective procedures requiring normovolemic hemodilution
Who may be able to join
- Those surgical procedures where ANH is included in the surgical plan and consent is obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Health System
Sacramento, California, 95832
About this study
Official title: The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution
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.
- Conditions
- Baseline, Hemodilution
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output
Metrics: Cardiac output stroke volume Stroke volume: variation
Measured: Baseline (Supine) Volume Replaced (S/P ANH)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startNov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Study never commenced, and is now closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BaselineStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179827
- Sponsor's protocol ID
- 362559
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution
- ClinicalTrials.gov ID
- NCT02179827
- Acronym / sponsor ID
- 362559
- Conditions
- Baseline, Hemodilution
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never commenced, and is now closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective procedures requiring normovolemic hemodilution
Key inclusion criteria (1 listed)
- Those surgical procedures where ANH is included in the surgical plan and consent is obtained
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cardiac output
Time frame: Baseline (Supine) Volume Replaced (S/P ANH)
Metrics: Cardiac output stroke volume Stroke volume: variation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Baseline and Hemodilution, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output (time frame: Baseline (Supine) Volume Replaced (S/P ANH)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.