EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution
NCT Number: NCT06544161
Acronym: CPMX2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Cirrhosis
Interventions: DEVICE: CPMX2
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: Compremium AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-17
Completion Date: 2025-06
Locations: University Hospital Bern, Bern, 3010, Switzerland

Summary:
Cirrhotic patients with an indication for intravenous albumin will undergo a venous compression technique of the external jugular vein plus an ultrasound examination before/after passive leg raise as well as before/after intravenous albumin infusion in order to study the dynamics of the intravascular volume status and to rule out volume overload.

Primary Outcome Measures: Absolute values and relative changes in external jugular vein (EJV) occlusion pressure, Reporting of absolute values (minimum and maximum mmHG) and relative changes in % in external jugular vein (EJV) occlusion pressure as measured with CPMX2., Immediately before (10 seconds) and 1 minute after sustained passive leg raising (PLR) as well as immediately before (10 seconds) and after IV albumin infusion (total duration of procedure approximately 2 hours/patient)|Feasibility of using CPMX2 in clinical conditions, Feasibility of using CPMX2 in clinical conditions will be evaluated through a usability and workflow questionnaire for the practitioner (description)., During the procedure which should last about 2 hours/patient
Secondary Outcome Measures: Absolute values and relative changes in inferior vena cava (IVC) maximal diameter, Reporting of absolute values and relative changes of the the inferior vena cava (IVC) maximal diameter (in mm) done with point-of-care ultrasound during the specified time frame (description)., Immediately before (10 seconds) and 1 minute after sustained passive leg raising (PLR) as well as immediately before (10 seconds) and after IV albumin infusion (total duration of procedure approximately 2 hours/patient)|Absolute values and relative changes in inferior vena cava (IVC) minimal diameter, Reporting of absolute values and relative changes of the the inferior vena cava (IVC) minimal diameter (in mm) done with point-of-care ultrasound during the specified time frame (description)., Immediately before (10 seconds) and 1 minute after sustained passive leg raising (PLR) as well as immediately before (10 seconds) and after IV albumin infusion (total duration of procedure approximately 2 hours/patient)|Absolute values and relative changes in inferior vena cava (IVC)-collapsibility index, Reporting of absolute values and relative changes of the the inferior vena cava (IVC)-collapsibility index (in %) done with point-of-care ultrasound during the specified time frame (description)., Immediately before (10 seconds) and 1 minute after sustained passive leg raising (PLR) as well as immediately before (10 seconds) and after IV albumin infusion (total duration of procedure approximately 2 hours/patient)|Evaluation of preliminary performance of CPMX2, Percentage of measurements / participants where CPMX2 measurement (outcome 1) \& ultrasound measurement (outcomes 3-5) are considered to be compatible, as determined by the investigator, Immediately before (10 seconds) and 1 minute after sustained passive leg raising (PLR) as well as immediately before (10 seconds) and after IV albumin infusion (total duration of procedure approximately 2 hours/patient)
Other Outcome Measures: Assessment of Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs), Safety of the procedure will be evaluated by systematically documenting Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs), and by monitoring the frequency and incidence of these events (description of the adverse events, number of participants)., During the procedure which should last about 2 hours/patient|Identification of potential risks using the CPMX2 device, Safety of the device and potential risks from using it will be assessed within the questionnaire for the practitioner and by evaluation of Device Deficiencies (description)., During the procedure which should last about 2 hours/patient