RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-24
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06645327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18
  2. 2. Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
  3. 3. Participants who are able to consent for themselves
  4. 4. Primary language is English
  1. 1. Age less than 18 years of age
  2. 2. Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)
  3. 3. Severe cardiac valvular pathologies or active congestive heart failure
  4. 4. Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.
  5. 5. Participants who are unable to consent for themselves
  6. 6. Primary language is something other than English

Contacts and Locations

Study Contact

Edward Stredny, MD
CONTACT
717-531-8521
estredny@pennstatehealth.psu.edu
Cynthia Reed, BS
CONTACT
717-531-0003
creed@pennstatehealth.psu.edu

Study Locations (Sites)

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2029-01

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Artery Bypass Grafting Surgery (CABG)