A study of the heart and kidney function during terlipressin and dobutamin treatment in patients with chronic liver disease (cirrhosis) and fluid retention (ascites)

Phase 1

• Conditions: iver cirrhosis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-002275-33-DK
• Lead Sponsor: Dept. of Gastroenterology, Universityhospital Odense

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-15
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

-The diagnosis of cirrhosis either verified by biopsy or based on established clinical, biochemical and ultrasonographic criteria
-Age 18-75 years
-ultrasonic vericated ascites within 3 months prior to inclusion

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 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Denied consent
- Patients under 18 or over 75 years of age
-Acute medical conditions such as ongoing infection, acute heart or lung disease, other conflicting diseases.
-Patients with known Heart, lung or kidney disease (ex. ischemic heart disease, heart failure, arrythmias, COLD, cronic kidney disease which is not hepatorenal syndrome, insulin dependent diabetes)
- Cerebral or psychiatric disease resulting in patients unable to qualified consent.
-Cancer including HCC
-Malignant arterial hypertension > 220/120 mmHg
-Hepatic encephalopathy > grade 2
-Serum-creatinin > 200 µmol/L
-Pregnancy (Urine-HCG negative within 7 days prior to inclusion in the trial) or breast feeding.
-Alcohol withdrawal symptoms such as tremor, increasing heart rate, increasing temperature.
-Treatment with vasoactive substances with cannot be paused 6 days prior to the trial and during the trial
- Allergy towards dobutamine or terlipressin
- Pheochromocytoma
. ideopatic hypertrofic subaortic stenosis

Study & Design

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