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

Paracentesis Clinical Trial

— Paracentesis  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02799160
• Other study ID #: EA2/052/16
• Status: Active, not recruiting
• Start date: October 1, 2016
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: June 1, 2024
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Paracentesis

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Humboldt-Universität zu Berlin, Technische Universität Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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 — View Citation

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. Gastroentero — View Citation

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.pm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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