Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Renal Failure
Intervention: Midodrine plus Albumin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s): Pere Ginès, MD, Principal Investigator, Affiliation: Hospital Clinic of Barcelona
Overall contact: Pere Ginès, MD, Phone: 0034932275400, Ext: 1713, Email: PGINES@clinic.ub.es
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.
Clinical Details
Official title: Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in glomerular filtration rate assessed by isotopic methods
Secondary outcome: changes in arterial pressure as assessed by continuous ambulatory arterial pressurechanges in plasma renin activity changes in aldosterone concentration changes in norepinephrine concentration
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pere Ginès, MD, Phone: 0034932275400, Ext: 1713, Email: PGINES@clinic.ub.es
Hospital Clinic, Villarroel 170,Barcelona, Barcelona 08036, Spain; Recruiting Mónica Guevara, MD, Sub-Investigator Gustavo H Pereira, MD, Sub-Investigator
Additional Information
Starting date: February 2010
Last updated: March 18, 2015
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