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NCT Number: NCT06645327

SSVC-CI During CABG

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
  • Participants who are able to consent for themselves
  • Primary language is English

Exclusion criteria

  • 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

Treatment and study plan

a change in operating room table position, which will mimic an IV fluid bolus

Other

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

Primary outcomes

  1. 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.

    • Responders increases by 12% or more following intervention
    • Non responders less than 12% change in CO following intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Reed, BS

CONTACT

[email protected]

717-531-0003 ext. 282465

Edward Stredny, MD

CONTACT

[email protected]

717-531-8521

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization

Acronym: SVC-CI

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 16, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.