Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Changes in glomerular filtration rate assessed by isotopic methods
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Midodrine, Albumin
Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Intervention: Midodrine plus Albumin (Drug)
Outcomes
Primary Outcomes
Changes in glomerular filtration rate assessed by isotopic methods
Time Frame: at 12 weeks of treatment
Secondary Outcomes
- changes in norepinephrine concentration(at 12 weeks of treatment)
- 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)
Investigators
Pere Gines
chief of hepatology unit
Hospital Clinic of Barcelona