Coronary Artery Bypass Grafting Surgery (CABG)SVC-CINCT06645327
SSVC-CI During CABG
An observational study of Coronary Artery Bypass Grafting Surgery (CABG), run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting Surgery (CABG)
- What is being tested?
- a change in operating room table position, which will mimic an IV fluid bolus
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
Who may be able to join
- Age ≥ 18
- Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
- Participants who are able to consent for themselves
- Primary language is English
Who cannot join
- Age less than 18 years of age
- Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)
- Severe cardiac valvular pathologies or active congestive heart failure
- Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.
- Participants who are unable to consent for themselves
- Primary language is something other than English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization
To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF \>40%) for group one and those with moderately to severely reduced LVEF (\<40%) in the second group.
Following group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.
- Being tested
- a change in operating room table position, which will mimic an IV fluid bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a change in operating room table position, which will mimic an IV fluid bolusOther
Cardiac Output (CO) measurements will be obtained at two separate time points: prior to sternotomy (opening of the chest) and after separation from cardiopulmonary bypass.
Intervention
- the participant will be placed in the reverse Trendelenburg position (head up) to 15 degrees for 60-90 seconds. CO measurement will be obtained
- the participant will be transitioned to the Trendelenburg position (head down) to 15 degrees for 60-90 seconds. CO measurement will be obtained
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | (LVEF>40%) Receives: Other: a change in operating room table position, which will mimic an IV fluid bolus | |
| Group 2 | (LVEF<40%), Receives: Other: a change in operating room table position, which will mimic an IV fluid bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine an appropriate cut-off value for the SVC-CI in participants with CAD undergoing isolated CABG to distinguish volume responders from non-responders.
- Responders increases by 12% or more following intervention
- Non responders less than 12% change in CO following intervention.
Measured: 10 minutes of time added to your surgery time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start24 Feb 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Grafting Surgery (CABG)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Stredny, MD, Milton S. Hershey Medical Center
- Investigators
- Edward Stredny, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645327
- Sponsor's protocol ID
- STUDY 24328
- Other IDs
- Study 24328
- Acronym
- SVC-CI
- Status last verified
- May 2026
- First submitted
- 15 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will depend if the data is shared in data bases and what kind of data bases. this has not been determined.
Publications
1. Charbonneau H, Riu B, Faron M, et al. Predicting preload responsiveness using simultaneous recordings of inferior and superior vena cavae diameters. Crit Care. 2014;18(5):473. 2. Hrishi AP, Sethuraman M, Menon G. Quest for the holy grail: Assessment of echo-derived dynamic parameters as predictors of fluid responsiveness in patients with acute aneurysmal subarachnoid hemorrhage. Ann Card Anaesth. 2018;21(3):243-248. 3. Vieillard-Baron A, Chergui K, Rabiller A, et al. Superior vena caval collapsibility as a gauge of volume status in ventilated septic patients. Intensive Care Med. 2004;30(9):1734-1739. 4. Vignon P, Repessé X, Bégot E, et al. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017;195(8):1022-1032.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization
- ClinicalTrials.gov ID
- NCT06645327
- Acronym / sponsor ID
- SVC-CI / STUDY 24328
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 16 Oct 2024 (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.
To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF \>40%) for group one and those with moderately to severely reduced LVEF (\<40%) in the second group.
Following group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: a change in operating room table position, which will mimic an IV fluid bolus(LVEF>40%) |
| Group 2 | – | Other: a change in operating room table position, which will mimic an IV fluid bolus(LVEF<40%), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
Key inclusion criteria (4 listed)
- Age ≥ 18
- Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
- Participants who are able to consent for themselves
- Primary language is English
Key exclusion criteria (6 listed)
- Age less than 18 years of age
- Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)
- Severe cardiac valvular pathologies or active congestive heart failure
- Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.
- Participants who are unable to consent for themselves
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 |
|---|---|---|
| a change in operating room table position, which will mimic an IV fluid bolusCardiac Output (CO) measurements will be obtained at two separate time points: prior to sternotomy (opening of the chest) and after separation from cardiopulmonary bypass. Intervention 1. the participant will be placed in the reverse Trendelenburg position (head up) to 15 degrees for 60-90 seconds. CO measurement will be obtained 2. the participant will be transitioned to the Trendelenburg position (head down) to 15 degrees for 60-90 seconds. CO measurement will be obtained | Other | Group 1, Group 2 |
Primary outcome
To determine an appropriate cut-off value for the SVC-CI in participants with CAD undergoing isolated CABG to distinguish volume responders from non-responders.
Time frame: 10 minutes of time added to your surgery time.
1. Responders increases by 12% or more following intervention 2. Non responders less than 12% change in CO following intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background1. Charbonneau H, Riu B, Faron M, et al. Predicting preload responsiveness using simultaneous recordings of inferior and superior vena cavae diameters. Crit Care. 2014;18(5):473. 2. Hrishi AP, Sethuraman M, Menon G. Quest for the holy grail: Assessment of echo-derived dynamic parameters as predictors of fluid responsiveness in patients with acute aneurysmal subarachnoid hemorrhage. Ann Card Anaesth. 2018;21(3):243-248. 3. Vieillard-Baron A, Chergui K, Rabiller A, et al. Superior vena caval collapsibility as a gauge of volume status in ventilated septic patients. Intensive Care Med. 2004;30(9):1734-1739. 4. Vignon P, Repessé X, Bégot E, et al. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017;195(8):1022-1032.
- Individual participant dataSharing planned: Undecided. It will depend if the data is shared in data bases and what kind of data bases. this has not been determined.
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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.
Edward Stredny, MD principal investigator
Milton S. Hershey Medical Center
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 Coronary Artery Bypass Grafting Surgery (CABG), run by Milton S. Hershey Medical Center 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Stredny, MD (717-531-8521, estredny@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine an appropriate cut-off value for the SVC-CI in participants with CAD undergoing isolated CABG to distinguish volume responders from non-responders. (time frame: 10 minutes of time added to your surgery time.). 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 NCT06645327, which also lists 1 linked publication.
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 7 May 2026.