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NCT06645327 · ClinicalTrials.gov registry record
Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization
A clinical trial of Coronary Artery Bypass Grafting Surgery (CABG), sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT06645327: Recruiting study of Coronary Artery Bypass Grafting Surgery (CABG), sponsored by Milton S. Hershey Medical Center.
NCT06645327 is a study of Coronary Artery Bypass Grafting Surgery (CABG) that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 120 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06645327, a study of Coronary Artery Bypass Grafting Surgery (CABG), is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
1. Responders increases by 12% or more following intervention 2. Non responders less than 12% change in CO following intervention.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2029-01 |
What NCT06645327 shows while recruiting
NCT06645327 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT06645327 reports a single indexed study location in Pennsylvania.
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).
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).
Who is sponsoring clinical trial NCT06645327?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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.
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