Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment (MAFRI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Clinic of Barcelona.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Clinic of Barcelona
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01133795
First received: May 19, 2010
Last updated: May 28, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cirrhosis Renal Failure |
Drug: Midodrine plus Albumin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Cirrhosis
Drug Information available for:
Midodrine hydrochloride
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- changes in arterial pressure as assessed by continuous ambulatory arterial pressure [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
- changes in plasma renin activity [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
- changes in aldosterone concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
- changes in norepinephrine concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Midodrine, Albumin
Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
|
Drug: Midodrine plus Albumin
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133795
Contacts
| Contact: Pere Ginès, MD | 0034932275400 ext 1713 | PGINES@clinic.ub.es |
Locations
| Spain | |
| Hospital Clinic | Recruiting |
| Villarroel 170,Barcelona, Barcelona, Spain, 08036 | |
| Sub-Investigator: Mónica Guevara, MD | |
| Sub-Investigator: Gustavo H Pereira, MD | |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
| Principal Investigator: | Pere Ginès, MD | Hospital Clinic Barcelona |
More Information
No publications provided
| Responsible Party: | Dr. Vicente Arroyo, Fundació Clínic per la Recerca Biomedica |
| ClinicalTrials.gov Identifier: | NCT01133795 History of Changes |
| Other Study ID Numbers: | MAFRI |
| Study First Received: | May 19, 2010 |
| Last Updated: | May 28, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
|
cirrhosis renal failure hepatorenal syndrome albumine midodrine |
Additional relevant MeSH terms:
|
Liver Cirrhosis Fibrosis Renal Insufficiency Liver Diseases Digestive System Diseases Pathologic Processes Kidney Diseases Urologic Diseases Midodrine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013