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| Name | Class |
|---|---|
| Compremium AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPMX2 | Device | The CPMX2 is a point-of-care device for non-invasive, real-time, and intermittent monitoring of vascular occlusion pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annalisa Berzigotti, Prof., MD | Insel Gruppe AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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) |
| 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 |
| D012816 | Signs and Symptoms |