Stroke Volume VariationNCT04177225
Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors
An observational study of Stroke Volume Variation and Diastolic Dysfunction, run by University of California, Davis at 1 site in United States.
Trial summary
This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function such as stroke volume variation (SVV) that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Volume Variation, Diastolic Dysfunction
- What is being tested?
- Trans thoracic Ultrasound Examination and Intravenous fluid administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 1 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective surgical procedures requiring arterial line pressure monitoring at the University of California Davis Medical Center Surgical Unit
Who may be able to join
- Patients Undergoing Elective surgical procedures where invasive arterial line pressure monitoring is a planned part of the intraoperative management
- Age greater than or equal to 18
- Procedures requiring general anesthesia and mechanical ventilation
Who cannot join
- Adults unable to provide consent
- Atrial Fibrillation or other significant active arrhythmia
- Emergency Procedures
- Hemodynamic instability requiring vasopressor and/or inotropic infusions
- Presence of an intra-aortic balloon pump
- Open thoracic procedures
Show all 10Show fewer
- Extremes of BMI less than 20 or greater than 40
- Pregnancy
- Prisoners
- Patient Refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Health System
Sacramento, California, 95817
About this study
Official title: Evaluation of Dynamic Monitors for the Prediction of Volume Responsiveness in Patients With and Without Diastolic Dysfunction
This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function such as stroke volume variation (SVV) that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.
Read the detailed description
This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function, such as stroke volume variation (SVV), that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.
Specific Aims:
- Determine the threshold for the predictive response of SVV with respect to increasing cardiac output for patients with and without diastolic dysfunction.
- Compare the trans thoracic ultrasound assessment of left ventricular diastolic function before and after the induction of general anesthesia.
- Conditions
- Stroke Volume Variation, Diastolic Dysfunction
- Being tested
- Trans thoracic Ultrasound Examination, Intravenous fluid administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans thoracic Ultrasound ExaminationProcedure or surgery
Ultrasound examination of cardiac function before and after induction of general anesthesia.
Intravenous fluid administrationOther
Intravenous fluids will be administered as a bolus in response to standard clinical indications
| Study group | Role | What they receive |
|---|---|---|
| Patients with normal diastolic function | Patients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their normal left ventricular diastolic function. Receives: Procedure: Trans thoracic Ultrasound Examination; Other: Intravenous fluid administration | |
| Patients with abnormal diastolic function | Patients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their abnormal left ventricular diastolic function. Receives: Procedure: Trans thoracic Ultrasound Examination; Other: Intravenous fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration.
The sensitivity of SVV as a predictor of the change in cardiac output in response to IV fluid administration will be determined by analysis of the Receiver Operator Characteristic (ROC) curves for each of the patient groups as distinguished by their pre-induction assessment of diastolic left ventricular function
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Grade assessment of diastolic function
Transthoracic ultrasound will be performed before and after the induction of general anesthesia to assess left ventricular diastolic function. Measurements of trans-mitral flow velocities and tissue Doppler velocities will be used to establish the grade of left ventricular diastolic function. The reproducibility of this measurement before and after the induction of anesthesia has ramifications for intra-operative measurement of diastolic function.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start7 Feb 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke Volume VariationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Fleming, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177225
- Sponsor's protocol ID
- 1380344
- Status last verified
- Feb 2021
- First submitted
- 19 Apr 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desai S, Hamilton Z, McCloskey L, Badakhsh O, Li D, Fleming NW. The effect of propofol on the grading of diastolic function: a prospective observational study. BMC Anesthesiol. 2025 Jul 30;25(1):376. doi: 10.1186/s12871-025-03260-2.
PubMed 40739534Abdallah AC, Song SH, Fleming NW. A retrospective study of the effects of a vasopressor bolus on systolic slope (dP/dt) and dynamic arterial elastance (Eadyn). BMC Anesthesiol. 2024 Jul 29;24(1):257. doi: 10.1186/s12871-024-02574-x.
PubMed 39075354
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dynamic Monitors for the Prediction of Volume Responsiveness in Patients With and Without Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT04177225
- Acronym / sponsor ID
- 1380344
- Conditions
- Stroke Volume Variation, Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function such as stroke volume variation (SVV) that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.
Detailed description
This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function, such as stroke volume variation (SVV), that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.
Specific Aims:
- Determine the threshold for the predictive response of SVV with respect to increasing cardiac output for patients with and without diastolic dysfunction.
- Compare the trans thoracic ultrasound assessment of left ventricular diastolic function before and after the induction of general anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with normal diastolic function | – | Procedure: Trans thoracic Ultrasound Examination, Other: Intravenous fluid administrationPatients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their normal left ventricular diastolic function. |
| Patients with abnormal diastolic function | – | Procedure: Trans thoracic Ultrasound Examination, Other: Intravenous fluid administrationPatients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their abnormal left ventricular diastolic function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgical procedures requiring arterial line pressure monitoring at the University of California Davis Medical Center Surgical Unit
Key inclusion criteria (3 listed)
- Patients Undergoing Elective surgical procedures where invasive arterial line pressure monitoring is a planned part of the intraoperative management
- Age greater than or equal to 18
- Procedures requiring general anesthesia and mechanical ventilation
Key exclusion criteria (10 listed)
- Adults unable to provide consent
- Atrial Fibrillation or other significant active arrhythmia
- Emergency Procedures
- Hemodynamic instability requiring vasopressor and/or inotropic infusions
- Presence of an intra-aortic balloon pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans thoracic Ultrasound ExaminationUltrasound examination of cardiac function before and after induction of general anesthesia. | Procedure or surgery | Patients with abnormal diastolic function, Patients with normal diastolic function |
| Intravenous fluid administrationIntravenous fluids will be administered as a bolus in response to standard clinical indications | Other | Patients with abnormal diastolic function, Patients with normal diastolic function |
Primary outcome
Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration.
Time frame: Through study completion, an average of 1 year
The sensitivity of SVV as a predictor of the change in cardiac output in response to IV fluid administration will be determined by analysis of the Receiver Operator Characteristic (ROC) curves for each of the patient groups as distinguished by their pre-induction assessment of diastolic left ventricular function
1 secondary outcome
Grade assessment of diastolic function
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 40739534Desai S, Hamilton Z, McCloskey L, Badakhsh O, Li D, Fleming NW. The effect of propofol on the grading of diastolic function: a prospective observational study. BMC Anesthesiol. 2025 Jul 30;25(1):376. doi: 10.1186/s12871-025-03260-2.
- Derived from this study: PubMed 39075354Abdallah AC, Song SH, Fleming NW. A retrospective study of the effects of a vasopressor bolus on systolic slope (dP/dt) and dynamic arterial elastance (Eadyn). BMC Anesthesiol. 2024 Jul 29;24(1):257. doi: 10.1186/s12871-024-02574-x.
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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.
Neal Fleming, MD principal investigator
University of California, Davis
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 Stroke Volume Variation and Diastolic Dysfunction, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 12 Feb 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177225, which also lists 2 linked publications.
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 12 Feb 2021.