Status:
COMPLETED
EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Compremium AG
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06544161
Start Date
July 17 2024
End Date
May 7 2025
Last Update
June 19 2025
Active Locations (1)
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1
University Hospital Bern
Bern, Switzerland, 3010