Midrodrine, octeotride and albumin for cirrhotic patients with functional renal impairment

Phase 1

• Conditions: cirrhotic patients; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-005825-36-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-06
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age between 18 and 80 years
- Liver Cirrhosis
- Serum Creatinine greater t han 1,2 mg/dL
- To have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Pregnancy
- Systolic blood pressure ? 150 mmHg and / or diastolic blood pressure ? 90 mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
- Use of antibiotics for seven days prior to inclusion in the study, except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
- Cardiac or respiratory failure
- Positive for the human immunodeficiency virus
- Urinary retention
- Ischemic heart disease or peripheral vascular disease.
- Narrow-angle glaucoma
- Cerebrovascular occlusions
- Aortic Aneurysm
- Thyrotoxicosis
- Pheochromocytoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified