Liver cirrhosis
Conditions
Interventions
Trade Name: Human Albumin 20%
Product Name: Human Albumin 20%
Product Code: Human Albumin 20%
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ALBUMINA HUMANA
Concentration unit: % perce
Sponsors
HOSPITAL CLINIC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with cirrhosis of any etiology, except which than can also affect the cardiac function (like hemocromatosis, Wilson disease or amiloidosis) Presence of diastolic dysfunction greater than stage 1 as determined by echocardiography Absence of shock, bacterial infection or digestive hemorrhage at the moment of the inclusion or during the previous week Age superior to18 and inferior to 75 years. Absence of some of the exclusion criteria Are the trial subjects under 18? 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Antecedents or presence of arterial hypertension that has required or no medical treatment. Antecedents or presence of ischemic or valvular cardiopathy , cardiac arrhythmias, and peripheral vasculophaty. Presence of severe anemia (Hb<9g/dL) Presence of chronic ostrutive pulmonary diseases Treatment with beta-blockers Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if plasma expansion with albumin is able to improve the diastolic dysfunction in patients with cirrhosis.;Secondary Objective: To evaluate the relation between the diastolic dysfunction and hepatic and renal function and the activity of the following endogenous vasoconstrictors : Renin, Angiotensin, Aldosterone, Noradrenaline, Atrial Natriuretic Factor, Vasopressin and cerebral Natriuretic Peptide (BNP).;Primary end point(s): Diastolic dysfunction in patients with cirrhosis before and after plasma expansion with albumin in order to evaluate if plasma expansion with albumin is able to improve the diastolic dysfunction in patients with cirrhosis. | — |
Countries
Spain
Outcome results
None listed