THORACIC FLUID ASSESSMENT BY DYNAMIC CONTRAST-ENHANCED MRI AND BIOIMPEDANCE SPECTROSCOPY: AN EXPLORATIVE STUDY IN HEALTHY SUBJECTS

Completed

• Conditions: intrathoracic bloodvolume; congestion; 10019280

• Registration Number: NL-OMON40803
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• Age >18 years
• Informed consent.
• Body mass index between 18 and 25

Exclusion Criteria

• end-stage renal or hepatic disease
• pregnancy
• mild or moderate renal insufficiency, (GFR<60 mL/min);
• risk for developing nephrogenic systemic fibrosis;
• general contra-indications to magnetic resonance imaging
• pro-inflammatory state, vascular endothelial dysfunction

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A. To optimize the DCE-MRI sequence parameters and to evaluate a reference<br /><br>values for indicator dilution curves derived parameters in healthy volunteers<br /><br>B. To evaluate whether bolus kinetic derived DCE-MRI parameters can track<br /><br>changes in response to fluid challenge/auto-transfusion in healthy volunteers<br /><br>C. To evaluate the agreement between changes in bolus kinetic parameters<br /><br>measured by DCE-MRI and changes in impedance measured by bio-impedance<br /><br>spectroscopy </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A. To evaluate the relationship between bolus kinetic parameters and RV and LV<br /><br>functional parameters.<br /><br>B. To evaluate reproducibility of MR based bolus kinetic parameters measurement<br /><br>and to evaluate sensitivity to MR sequence parameters.</p><br>