Clinical trial NCT02799160: Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
Official title: Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paracentesis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Technische Universität Berlin
name: Humboldt-Universität zu Berlin
First posted: 2016-06-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change over time of stroke-volume (milliliter) before, under and after paracentesis
timeFrame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
measure: Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis
timeFrame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Secondary outcomes:
measure: Incidence of adverse effects
timeFrame: Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Wiedenmann Betram, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
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.pm9247479.
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: 10.1097/00042737-200403000-00016.
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. Gastroenterology. 1994 Mar;106(3):709-19. doi: 10.1016/0016-5085(94)90706-4.
citation: 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.