Non-invasive pressure measurement of the superficial jugular vein in patients with liver cirrhosis requiring albumin infusion due to liver cirrhosis
Résumé de l'étude
In cases of advanced liver cirrhosis with large fluid accumulations in the abdomen and sudden deterioration of kidney function, an infusion of albumin (a body protein produced by the liver, also important for fluid balance) is administered for treatment. This aims to avoid serious complications and/or prevent an unstable circulatory situation. In our research project, we want to find out if it is possible to determine the fluid status in the body with a new device (CPMX2). To do this, the CPMX2 device measures the pressure of the superficial jugular vein. This should allow for early detection of the risk of fluid overload. We will also monitor this using an ultrasound examination. The device for measuring the pressure of the superficial jugular vein, CPMX2, has not yet received approval in Switzerland or a CE certification. The measurement with CPMX2 is comparable to an ultrasound examination.
(BASEC)
Intervention étudiée
Harmless pressure measurement and ultrasound examination of the external jugular vein before and after leg elevation, as well as before and after leg elevation and albumin infusion for patients requiring an albumin infusion.
(BASEC)
Maladie en cours d'investigation
Liver cirrhosis
(BASEC)
1. Inpatient and outpatient patients with liver cirrhosis treated at the University Hospital for Visceral Surgery and Medicine, Hepatology at Inselspital Bern. 2. Age ≥ 18 years 3. Indication for intravenous albumin infusion according to current guidelines 4. Available transthoracic echocardiography to assess right heart function within the last 3 months prior to study inclusion. (BASEC)
Critères d'exclusion
1. Patients admitted to the intermediate care station or intensive care unit at the time of albumin infusion 2. Previous intravenous albumin infusion within the last 5 days 3. Contraindication to leg elevation (e.g., increased intracranial pressure) 4. Contraindication to albumin infusion (e.g., anaphylactic reactions to albumin) 5. Right heart failure in the medical history 6. Clinical signs of pulmonary edema, hemodynamic instability/shock 7. Anatomical IVC anomalies, such as IVC stenosis and/or thrombosis 8. Previous orthotopic liver transplantation 9. Patients unable to provide informed consent (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Insel Gruppe AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Daniel Segna
+41 31 63 2 02 61
daniel.segna@clutterinsel.chInsel Gruppe AG
(BASEC)
Informations générales
Insel Gruppe AG,
+41 31 632 02 61;+41 31 632 02 61
daniel.segna@clutterinsel.ch(ICTRP)
Informations générales
Insel Gruppe AG
(ICTRP)
Informations scientifiques
Insel Gruppe AG,
+41 31 632 02 61;+41 31 632 02 61
daniel.segna@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
14.06.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06544161 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
MEASUREMENT OF OCCLUSION PRESSURE OF THE EXTERNAL JUGULAR VEIN FOR INTRAVASCULAR VOLUME ASSESSMENT IN CIRRHOTIC PATIENTS DURING INTRAVENOUS ALBUMIN SUBSTITUTION (BASEC)
Titre académique
Measurement of Occlusion Pressure of the External Jugular Vein for Intravascular Volume Assessment in Cirrhotic Patients During Intravenous Albumin Substitution. (ICTRP)
Titre public
EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution (ICTRP)
Maladie en cours d'investigation
Liver Cirrhosis (ICTRP)
Intervention étudiée
Device: CPMX2 (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Absolute values and relative changes in external jugular vein (EJV) occlusion pressure;Feasibility of using CPMX2 in clinical conditions (ICTRP)
Absolute values and relative changes in inferior vena cava (IVC) maximal diameter;Absolute values and relative changes in inferior vena cava (IVC) minimal diameter;Absolute values and relative changes in inferior vena cava (IVC)-collapsibility index;Evaluation of preliminary performance of CPMX2 (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Compremium AG (ICTRP)
Contacts supplémentaires
Annalisa Berzigotti, Prof., MD;Daniel Segna, MD;Daniel Segna, MD, daniel.segna@insel.ch, +41 31 632 02 61;+41 31 632 02 61, Insel Gruppe AG, (ICTRP)
ID secondaires
2024-D0007 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06544161 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible