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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Paracentesis

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Technische Universität Berlin; Humboldt-Universität zu Berlin
• Investigators: Study Director: Wiedenmann Betram, Prof. Dr. med., Charite Universitatsmedizin Berlin

Publications and helpful links

General Publications

• Albillos A, de la Hera A, Gonzalez M, Moya JL, Calleja JL, Monserrat J, Ruiz-del-Arbol L, Alvarez-Mon M. Increased lipopolysaccharide binding protein in cirrhotic patients with marked immune and hemodynamic derangement. Hepatology. 2003 Jan;37(1):208-17. doi: 10.1053/jhep.2003.50038.
• Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997 Aug;113(2):579-86. doi: 10.1053/gast.1997.v113.pm9247479.
• Coll S, Vila MC, Molina L, Gimenez MD, Guarner C, Sola R. Mechanisms of early decrease in systemic vascular resistance after total paracentesis: influence of flow rate of ascites extraction. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):347-53. doi: 10.1097/00042737-200403000-00016.
• Pozzi M, Osculati G, Boari G, Serboli P, Colombo P, Lambrughi C, De Ceglia S, Roffi L, Piperno A, Cusa EN, et al. Time course of circulatory and humoral effects of rapid total paracentesis in cirrhotic patients with tense, refractory ascites. Gastroenterology. 1994 Mar;106(3):709-19. doi: 10.1016/0016-5085(94)90706-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 29, 2017
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimated): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EA2/052/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO