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RECRUITING

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

NCT06645327 · View on ClinicalTrials.gov ↗

Study 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. 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.

Interventions

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

Study Locations (1)

Pennsylvania

  • Penn State Hershey Medical Center — Hershey

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-02-24
Est. Completion 2029-01

Sponsor

Milton S. Hershey Medical Center

277 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06645327

The ClinicalTrials.gov registry entry for NCT06645327 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Coronary Artery Bypass Grafting Surgery (CABG) appearing as the primary indexed condition, and to 1 intervention — of which a change in operating room table position, which will mimic an IV fluid bolus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06645327 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06645327 about?

NCT06645327 is a clinical study titled "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 pulm...

What is the current status of trial NCT06645327?

This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2025-02-24. Estimated completion is 2029-01.

What conditions does trial NCT06645327 study?

This clinical trial studies the following conditions: Coronary Artery Bypass Grafting Surgery (CABG). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06645327?

The interventions under investigation include: a change in operating room table position, which will mimic an IV fluid bolus (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06645327?

This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06645327 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial