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

Active, not recruiting

• Conditions: Paracentesis

• Registration Number: NCT02799160
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Study Start: 2016-10-01
• Primary Completion: 2017-11-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change over time of stroke-volume (milliliter) before, under and 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	Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
Change over time of arterial pressure (millimeter of mercury) before, under and 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	Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse effects	Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis	Clinical, laboratory and haemodynamic adverse effects of paracentesis

Trial Locations

Locations (1)

Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany