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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 pressure

changes 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

Page last updated: August 23, 2015

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