EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution

NCT06544161 | Completed

• 1 other identifier: 2024-D0007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Cirrhosis

Keywords

Cirrhosis; Albumin; Volume overload

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Absolute values and relative changes in inferior vena cava (IVC) maximal diameter

  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

  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

  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

  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 Outcomes (2)

• Assessment of Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)

  During the procedure which should last about 2 hours/patient

• Identification of potential risks using the CPMX2 device

  During the procedure which should last about 2 hours/patient

Study Arms (1)

CPMX2 Arm

OTHER

This study is a single-center, single arm, prospective, exploratory proof of concept study. 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.

Device: CPMX2

Interventions

CPMX2 DEVICE

The CPMX2 is a point-of-care device for non-invasive, real-time, and intermittent monitoring of vascular occlusion pressure.

CPMX2 Arm

Eligibility Criteria

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

You may qualify if:

• In- and outpatients with liver cirrhosis of any etiology, diagnosed by either liver histology or compatible biochemical, imaging and clinical parameters, being treated at the department of Visceral Surgery and Medicine at Inselspital Bern, University Hospital Bern, Switzerland.
• Age ≥ 18 years
• Indication for IV albumin infusion according to current EASL guidelines\[11\] and BAVENO VII consensus recommendations\[12\] including large volume paracentesis, spontaneous bacterial peritonitis (SBP), AKI with/without HRS.

You may not qualify if:

• Patients admitted to intermediate care unit or intensive care unit at the time of albumin infusion
• Previous IV albumin infusion within the last 5 days
• Contraindication to the PLR test (i.e. increased intracranial pressure)
• Contraindication to albumin infusion (i.e. anaphylactic reactions against albumin)
• History of right heart failure
• Clinical evidence of lung edema, hemodynamic instability/shock
• Anatomic IVC abnormalities, such as IVC stenosis and/or thrombosis
• History of orthotopic liver transplant
• Patients unable to provide informed consent

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Compremium AG: collaborator

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Edema

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Annalisa Berzigotti, Prof., MD

  Insel Gruppe AG

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 9, 2024
• Study Start: July 17, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)