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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967315 on ClinicalTrials.gov