Effects of Changes in Fluid Status on Right Ventricular Volumes and Function

NCT02967315 | Completed

• 3 other identifiers: 2018-03992013-0276SMPH/SURGERY/CARDIOTHORACIC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postload volume status

  The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters \[ml\]); Ejection fraction (%); pulmonary regurgitation

  24 months

Study Arms (1)

Study Group

EXPERIMENTAL

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

Procedure: Cardiac Magnetic Resonance Imaging (CMRI); Procedure: Central venous line placement; Procedure: Chest X-ray; Procedure: Fluid administration; Procedure: Blood Draw; Procedure: Pregnancy test; Procedure: Electrocardiogram

Interventions

Cardiac Magnetic Resonance Imaging (CMRI) PROCEDURE

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.

Study Group

Central venous line placement PROCEDURE

An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.

Study Group

Chest X-ray PROCEDURE

A chest X-ray will be performed for safety reasons to rule out pneumothorax (\< 1% risk) after central line placement.

Study Group

Fluid administration PROCEDURE

Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.

Study Group

Blood Draw PROCEDURE

One to two teaspoons of blood will be drawn for basic metabolic panel.

Study Group

Pregnancy test PROCEDURE

A urine pregnancy test will be performed in female subjects.

Study Group

Electrocardiogram PROCEDURE

12 lead ECG

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TOF patients who have had repair using a transannular patch.
• Patients that present with free pulmonary insufficiency.
• Are older than 18 years.

You may not qualify if:

• Patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (VSD), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status
• Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
• 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.
• 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.
• Patients with renal failure and renal insufficiency
• Patients with uncompensated heart failure
• Cancer patients
• Latex allergic patients
• Patients with diabetes
• Pregnant females
• Prisoners
• Individuals who lack consent capacity

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

X-Rays; Hypodermoclysis; Blood Specimen Collection; Pregnancy Tests

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Obstetrical and Gynecological

Study Officials

• Petros V Anagnostopoulos, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 18, 2016
• Study Start: June 6, 2014
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)