Viewing Study NCT06544161



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06544161
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-22

Brief Title: EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution
Sponsor: None
Organization: None

Study Overview

Official Title: Measurement of Occlusion Pressure of the External Jugular Vein for Intravascular Volume Assessment in Cirrhotic Patients During Intravenous Albumin Substitution
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CPMX2
Brief Summary: Cirrhotic patients with an indication for intravenous albumin will undergo a venous compression technique of the external jugular vein plus an ultrasound examination beforeafter passive leg raise as well as beforeafter intravenous albumin infusion in order to study the dynamics of the intravascular volume status and to rule out volume overload
Detailed Description: Cirrhotic patients with portal hypertension are prone to develop ascites Current guidelines recommend volume expansion using intravenous IV albumin infusion for several circumstances such as large volume paracentesis development of spontaneous bacterial peritonitis SBP and treatment of acute kidney injury AKI withwithout hepatorenal syndrome HRS However current dosages for IV albumin infusion do not consider individual intravascular volume status before its administration In addition there are increasing reports of volume overload following volume expansion with albumin in cirrhotic patients within and beyond current indications Non-invasive point-of-care ultrasound POCUS of the inferior vena cava IVC diameter and collapsibility index IVCCI using echocardiography has been proposed for assessing volume status in patients with cardiac disease and for predicting fluid responsiveness in critically ill patients In addition determining the occlusion pressure of the external jugular vein EJV has been proposed as a surrogate parameter for the estimation of central venous pressure CVP In 2005 Baumann et al introduced a novel method for non-invasive venous pressure measurement by combining ultrasound and a tissue pressure manometer Peripheral occlusion pressure was measured non-invasively via jugular and basilic vein Although good correlation with invasive CVP measurements was achieved and measurements showed potential to reflect patients tolerable reserve with respect to fluid-overload in intensive care and cardiologic patients its application in cirrhotic patients needs to be studied

In this study the investigators aim to assess whether compression of the EJV is feasible in the cirrhotic patients population and observe the change in EJV occlusion pressure determined by the CPMX2 in parallel to sonographic assessment of the IVC diameters and IVCCI as indicators for changes in intravascular volume status in patients with decompensated cirrhosis and an indication for intravenous albumin substitution

The objective of this clinical investigation is to assess safety and feasibility of external jugular vein EJV occlusion pressure measured non-invasively with CPMX2 in patients with decompensated cirrhosis with an indication for albumin infusion

Data gathered in this study will help define hypotheses to be used in future clinical investigations about the role of absolute values andor changes in EJV occlusion pressure in characterizing intravascular volume status and its change after passive leg elevation as an indirect test for fluid responsiveness and intravenous albumin infusion for volume expansion in patients with decompensated cirrhosis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None