Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
NCT ID: NCT02967315
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2014-06-06
2021-03-18
Brief Summary
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Detailed Description
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1. To establish a correlation between the changes in preload volume status and RV size and function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI.
2. To assess the effects of preload status on the measured severity of pulmonary regurgitation (PR).
3. To assess the effects of preload status on the left ventricular (LV) size
This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
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.
Central venous line placement
An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
Chest X-ray
A chest X-ray will be performed for safety reasons to rule out pneumothorax (\< 1% risk) after central line placement.
Fluid administration
Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
Blood Draw
One to two teaspoons of blood will be drawn for basic metabolic panel.
Pregnancy test
A urine pregnancy test will be performed in female subjects.
Electrocardiogram
12 lead ECG
Interventions
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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.
Central venous line placement
An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
Chest X-ray
A chest X-ray will be performed for safety reasons to rule out pneumothorax (\< 1% risk) after central line placement.
Fluid administration
Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
Blood Draw
One to two teaspoons of blood will be drawn for basic metabolic panel.
Pregnancy test
A urine pregnancy test will be performed in female subjects.
Electrocardiogram
12 lead ECG
Eligibility Criteria
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Inclusion Criteria
2. Patients that present with free pulmonary insufficiency.
3. Are older than 18 years.
Exclusion Criteria
2. Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
3. Patients who have significant residual right-sided obstruction (i.e. patients who have residual RVOT obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from RV dilation and from deterioration of the RV function.
4. Patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including:
* pulmonary atresia and VSD
* patients with anomalous coronary crossing the right ventricular outflow tract (RVOT) and
* patients with TOF-absent pulmonary valve syndrome.
5. Patients with renal failure and renal insufficiency
6. Patients with uncompensated heart failure
7. Cancer patients
8. Latex allergic patients
9. Patients with diabetes
10. Pregnant females
11. Prisoners
12. Individuals who lack consent capacity
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Petros V Anagnostopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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2013-0276
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/CARDIOTHORACIC
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0399
Identifier Type: -
Identifier Source: org_study_id
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