Liver CirrhosisCPMX2NCT06544161
EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution
A study testing CPMX2 in people with Liver Cirrhosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- CPMX2
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jul 2024to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Available transthoracic echocardiography assessing right heart function within maximum 3 months from study inclusion.
Who cannot join
- 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
Show all 9Show fewer
- Anatomic IVC abnormalities, such as IVC stenosis and/or thrombosis
- History of orthotopic liver transplant
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Occlusion Pressure of the External Jugular Vein for Intravascular Volume Assessment in Cirrhotic Patients During Intravenous Albumin Substitution.
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.
Read the 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) with/without 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 and/or 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.
- Conditions
- Liver Cirrhosis
- Being tested
- CPMX2
- Keywords
- Cirrhosis, Albumin, Volume overload
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMX2Device
The CPMX2 is a point-of-care device for non-invasive, real-time, and intermittent monitoring of vascular occlusion pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CPMX2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start17 Jul 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Compremium AG
- Responsible party
- Sponsor
- Investigators
- Annalisa Berzigotti, Prof., MD, Study director, Insel Gruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544161
- Sponsor's protocol ID
- 2024-D0007
- Acronym
- CPMX2
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Occlusion Pressure of the External Jugular Vein for Intravascular Volume Assessment in Cirrhotic Patients During Intravenous Albumin Substitution.
- ClinicalTrials.gov ID
- NCT06544161
- Acronym / sponsor ID
- CPMX2 / 2024-D0007
- Conditions
- Liver Cirrhosis
- Keywords
- Cirrhosis, Albumin, Volume overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Compremium AG
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) with/without 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 and/or 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPMX2 Arm | Other | Device: CPMX2This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Available transthoracic echocardiography assessing right heart function within maximum 3 months from study inclusion.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPMX2The CPMX2 is a point-of-care device for non-invasive, real-time, and intermittent monitoring of vascular occlusion pressure. | Device | CPMX2 Arm |
Primary outcome
Absolute values and relative changes in external jugular vein (EJV) occlusion pressure
Time frame: 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)
Reporting of absolute values (minimum and maximum mmHG) and relative changes in % in external jugular vein (EJV) occlusion pressure as measured with CPMX2.
Feasibility of using CPMX2 in clinical conditions
Time frame: During the procedure which should last about 2 hours/patient
Feasibility of using CPMX2 in clinical conditions will be evaluated through a usability and workflow questionnaire for the practitioner (description).
4 secondary outcomes
Absolute values and relative changes in inferior vena cava (IVC) maximal diameter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annalisa Berzigotti, Prof., MD study director
Insel Gruppe AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPMX2 in people with Liver Cirrhosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute values and relative changes in external jugular vein (EJV) occlusion pressure (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.