Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations

Study Overview
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Brief Summary
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This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation

Detailed Description
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Ascites is one of the common complications in advanced liver cirrhosis. Large-volume paracentesis (LVP) is a widely used symptomatic intervention to remove large amounts of peritoneal fluid. Despite a low rate of interventional-associated complications like fistula or non life-threatening bleeding LVP induces an impairment of circulatory function. The hypothesis is that haemodynamic changes can be detected by non-invasive monitoring and that these haemodynamic changes could be associated to postinterventional organ dysfunction or complications. Additionally the investigators hypothesize that paracentesis-induced circulatory dysfunction could also be associated to present clinical and laboratory signs of inflammation or infection and could influenced by increased viable and non-viable bacterial translocation.

Official Title
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Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations

Conditions
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Paracentesis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male Patients between 18-70 years with liver cirrhosis and ascites Indication for paracentesis Exclusion Criteria: Infectious disease in the last 4 weeks Active alcohol-consumption or missing data of alcohol use Missing inform consent Missing speech comprehension Neurological or psychiatric disease that compromise consenting Hepatic encephalopathy stage III (West-Haven criteria) Heart failure NYHA IV Renal insufficiency or hepatorenal syndrome Atrial fibrillation Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of stroke-volume (milliliter) before, under and after paracentesis | Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis | 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis | 
| Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis | Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis | 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effects | Clinical, laboratory and haemodynamic adverse effects of paracentesis | Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis |