An observational study in Paracentesis, sponsored by Charite University, Berlin, Germany. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Charite University, Berlin, Germany · Observational
This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation
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.
Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)
Exclusion Criteria:
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
Time frame: 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
Time frame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Incidence of adverse effects
Clinical, laboratory and haemodynamic adverse effects of paracentesis
Time frame: Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis
Plan to share: No
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany