patients with decompensated liver cirrhosis and refractery ascites indicated for large /more then 5 L/ volume paracentesis
Conditions
Interventions
Trade Name: HUMAN ALBUMIN 20% IMMUNO
Product Name: HUMAN ALBUMIN 20% IMMUNO
Pharmaceutical Form: Intravenous infusion
Sponsors
Hospital Trebic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is 18 years of age or older male or non-pregnant female • Decompensate liver cirrhosis with refractory ascites and indication for paracetesis more then 5 L. • Informed consent in accordance with Act 129/2003 Sb., §34, sect. 8 or 3d and GCP E6, sect. 4.8.15 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Woman who are pregnant or lactating • Known or suspected hypersensitivity to albumin • Acute coronary artery disease • Pulmonary oedema, decompensation of heart failure • Documented sustained severe hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg) at enrollment • Subject has been previously enrolled in this study • Renal and postrenal anuria • Bleeding form esophageal varices in last six month • Severe anemia (Hb <80g/L) • Hemorrhagic diathesis • Known active malignancy or other serious medical comorbidity such that the subject's life expectancy is <12 month • Patients with ongoing significant active alcohol abuse will not be enrolled • Subject is part of the staff personnel directly involved with this study, or is a family member of the investigational staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In our project we plan to perform randomized controlled study comparing 2 different doses of albumin (5g ang 10g per liter of fluid removed) in patietns with refractory ascites after large volume paracentesis. The trial should answer according to actual guidelines (2009) unresolved questions, regarding efficacy of various doses of albumin, cost-effectivness of albumin administration and survival a the specific study endpoint. ;Secondary Objective: In our study we will perform echocardiographic assessment and we will bring direct hemodynamic changes after large paracentesis followed by various albumin substitution. Last but not least, we gain knowledge about BNP levels during these changes. Another endpoint will be time to readmission to the hospital during follow-up.;Primary end point(s): •survival •renal functions •Child, MELD score •albumin level •blood preasure, heart rate, vasopressor/s/ need •cardiac output/index, BNP level | — |
Countries
Czech Republic
Outcome results
None listed