Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
NCT02967315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2021-04-14
Summary
The purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after Tetralogy of Fallot (TOF) repair.
Conditions
- Tetralogy of Fallot
Interventions
- PROCEDURE
-
Cardiac Magnetic Resonance Imaging (CMRI)
There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast. The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast.
- PROCEDURE
-
Central venous line placement
An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
- PROCEDURE
-
Chest X-ray
A chest X-ray will be performed for safety reasons to rule out pneumothorax (\< 1% risk) after central line placement.
- PROCEDURE
-
Fluid administration
Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
- PROCEDURE
-
Blood Draw
One to two teaspoons of blood will be drawn for basic metabolic panel.
- PROCEDURE
-
Pregnancy test
A urine pregnancy test will be performed in female subjects.
- PROCEDURE
-
Electrocardiogram
12 lead ECG
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Petros V Anagnostopoulos, MD · University of Wisconsin, Madison
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-06
- Primary Completion
- 2021-03-18
- Completion
- 2021-03-18
Countries
- United States
Study Locations
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