Measuring pressure in the jugular vein to assess fluid levels in cirrhotic patients receiving albumin
Measurement of Occlusion Pressure of the External Jugular Vein for Intravascular Volume Assessment in Cirrhotic Patients During Intravenous Albumin Substitution.
This study tests a new way to measure fluid levels in cirrhotic patients receiving albumin to see if it helps manage their treatment better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06544161 on ClinicalTrials.gov |
What this trial studies
This study involves cirrhotic patients who require intravenous albumin infusion. Participants will undergo a non-invasive venous compression technique on the external jugular vein, along with ultrasound examinations before and after a passive leg raise and albumin infusion. The goal is to evaluate the dynamics of intravascular volume status and identify any potential volume overload. This approach aims to improve the management of fluid therapy in patients with liver cirrhosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with liver cirrhosis requiring intravenous albumin infusion according to established guidelines.
Not a fit: Patients in intensive care or those with contraindications to the study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and safer fluid management for cirrhotic patients receiving albumin.
How similar studies have performed: While the approach of using non-invasive methods for assessing volume status is gaining traction, this specific combination of techniques has not been widely tested in cirrhotic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Bern
- University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Daniel Segna, MD
- Email: daniel.segna@insel.ch
- Phone: +41 31 632 02 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.