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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Page 1 of 1 (1 locations)

1

University Hospital Bern

Bern, Switzerland, 3010