Cirrhosis, Renal Failure
Conditions
Keywords
cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine
Brief summary
The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.
Detailed description
Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.
Interventions
DRUGMidodrine plus Albumin
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Liver Cirrhosis * Serum Creatinine greater than 1,2 mg/dL * to have given written informed consent
Exclusion criteria
* pregnancy * Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg * Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts * Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis * infection by HIV * contraindications for albumin and/or midodrine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in glomerular filtration rate assessed by isotopic methods | at 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| changes in arterial pressure as assessed by continuous ambulatory arterial pressure | at 12 weeks of treatment |
| changes in plasma renin activity | at 12 weeks of treatment |
| changes in aldosterone concentration | at 12 weeks of treatment |
| changes in norepinephrine concentration | at 12 weeks of treatment |
Countries
Spain
Outcome results
None listed