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

Renal and cardiac effects of terlipressin and dobutamin in cirrhosis and ascites. A randomised study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002275-33-DK

Enrollment

Registered

2014-01-15

Start date

2014-01-15

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis

Interventions

Trade Name: Glypressin (terlipressin) Product Name: terlipressin Pharmaceutical Form: Concentrate and solvent for solution for injection Pharmaceutical form of the placebo: Solution for injection Rout

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Many patients with cirrhosis will die of renal failure - the hepatorenal syndrome, which has a median survival of less than 1 month. Hepatorenal syndrome is treated with terlipressin, which increases blood pressure and improves renal function. However, terlipressin also causes a decline in cardiac function, which is unfortunate, since the renal function relies on a sufficient cardiac output. This may explain why only half of the patients respond to this treatment. We aim to investigate if renal function in patients with cirrhosis and ascites can be improved by combining terlipressin with dobutamin - a drug that increases cardiac function. Dobutamin increases cardiac output primarily by increasing heart rate.;Secondary Objective: Not applicable;Primary end point(s): Primary end points: Glomerular filtration rate (GFR), and effective renal blood flow (ERPF);Timepoint(s) of evaluation of this end point: End points are evaluated 3 times during the trial: 1) Baseline (0-60 min) 2) Period 1 (60-150 min): patients receive either dobutamine, terlipressin or placebo (natriumchloride) 3) Period 2 (150-240 min): Patients receiving dobutamine in period 1 receive terlipressin, patients receiving terlipressin in period 1 receive dobutamin. The placebo group continue with natriumchloride	—

Measure

Time frame

Main Objective: Many patients with cirrhosis will die of renal failure - the hepatorenal syndrome, which has a median survival of less than 1 month. Hepatorenal syndrome is treated with terlipressin, which increases blood pressure and improves renal function. However, terlipressin also causes a decline in cardiac function, which is unfortunate, since the renal function relies on a sufficient cardiac output. This may explain why only half of the patients respond to this treatment. We aim to investigate if renal function in patients with cirrhosis and ascites can be improved by combining terlipressin with dobutamin - a drug that increases cardiac function. Dobutamin increases cardiac output primarily by increasing heart rate.;Secondary Objective: Not applicable;Primary end point(s): Primary end points: Glomerular filtration rate (GFR), and effective renal blood flow (ERPF);Timepoint(s) of evaluation of this end point: End points are evaluated 3 times during the trial: 1) Baseline (0-60 min) 2) Period 1 (60-150 min): patients receive either dobutamine, terlipressin or placebo (natriumchloride) 3) Period 2 (150-240 min): Patients receiving dobutamine in period 1 receive terlipressin, patients receiving terlipressin in period 1 receive dobutamin. The placebo group continue with natriumchloride

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are: clearance of water, sodium, and lithium (CH2O, CNa, CLi), osmolar clearance, concentrations of hormones (renin, noradrenaline, aldosterone, proANP, proBNP), and cardiac variables (cardiac output, cardiac index, heart rate, mean arterial pressure). The study is of pathophysiological nature with one day of investigations, therefore we do not use classical end points such as treatment failure or death. The study is not confirmatory, hence several end points are applied.;Timepoint(s) of evaluation of this end point: End points are evaluated 3 times during the trial: 1) Baseline (0-60 min) 2) Period 1 (60-150 min): patients receive either dobutamine, terlipressin or placebo (natriumchloride) 3) Period 2 (150-240 min): Patients receiving dobutamine in period 1 receive terlipressin, patients receiving terlipressin in period 1 receive dobutamin. The placebo group continue with natriumchloride	—

Measure

Time frame

Secondary end point(s): Secondary end points are: clearance of water, sodium, and lithium (CH2O, CNa, CLi), osmolar clearance, concentrations of hormones (renin, noradrenaline, aldosterone, proANP, proBNP), and cardiac variables (cardiac output, cardiac index, heart rate, mean arterial pressure). The study is of pathophysiological nature with one day of investigations, therefore we do not use classical end points such as treatment failure or death. The study is not confirmatory, hence several end points are applied.;Timepoint(s) of evaluation of this end point: End points are evaluated 3 times during the trial: 1) Baseline (0-60 min) 2) Period 1 (60-150 min): patients receive either dobutamine, terlipressin or placebo (natriumchloride) 3) Period 2 (150-240 min): Patients receiving dobutamine in period 1 receive terlipressin, patients receiving terlipressin in period 1 receive dobutamin. The placebo group continue with natriumchloride

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Countries

Denmark

Contacts

Public ContactAleksander Krag

Dept. Gastroenterology, Universityhospital Odense

Aleksander.krag@health.sdu.dk004529647719

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026