cirrhotic patients
Conditions
Interventions
Trade Name: Albúmina Humana Grifols 20% solución para perfusión
Product Name: Albúmina Humana Grifols 20% solución para perfusión
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Albúmi
Sponsors
Fundació Clinic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 80 years - Liver Cirrhosis - Serum Creatinine greater t han 1,2 mg/dL - To have given written informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Pregnancy - Systolic blood pressure ? 150 mmHg and / or diastolic blood pressure ? 90 mmHg - Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts - Use of antibiotics for seven days prior to inclusion in the study, except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis) - Cardiac or respiratory failure - Positive for the human immunodeficiency virus - Urinary retention - Ischemic heart disease or peripheral vascular disease. - Narrow-angle glaucoma - Cerebrovascular occlusions - Aortic Aneurysm - Thyrotoxicosis - Pheochromocytoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of albumin administration, midodrine and octreotide on renal function in patients with liver cirrhosis with serum creatinine above 1.2 mg / dL.;Secondary Objective: 1. To assess the relationship between treatment response and the activity of endogenous vasoactive systems, plasma renin activity, plasma aldosterone, norepinephrine, vasopressin and atrial natriuretic peptide. 2. To assess the relationship between response to treatment with blood pressure changes measured by Holter tension. 3. Evaluate the deterioration of renal function in the short term after stopping treatment in responders. 4. To evaluate the presence of bacterial DNA in blood of patients at different times and its correlation with response to treatment.;Primary end point(s): Change in glomerular filtration rate measured by isotopic tests at 12 weeks of starting treatment.;Timepoint(s) of evaluation of this end point: Change in glomerular filtration rate measured by isotopic tests at 12 weeks of starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Changes in plasma renin activity, plasma aldosterone and norepinephrine at 4, 12 and 16 weeks. ? Changes in blood pressure measured by Holter voltage at 4, 12 and 16 weeks. ? Changes in renal function at 4 weeks after cessation of treatment (week 16);Timepoint(s) of evaluation of this end point: ? Changes in plasma renin activity, plasma aldosterone and norepinephrine at 4, 12 and 16 weeks. ? Changes in blood pressure measured by Holter voltage at 4, 12 and 16 weeks. ? Changes in renal function at 4 weeks after cessation of treatment (week 16) | — |
Countries
Spain
Contacts
Public ContactFarmacología Clínica -CTU- Hospital
Fundació clinic per a la Recerca Biomèdica
Outcome results
None listed