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

NCT02799160 | Active Not Recruiting

• 1 other identifier: EA2/052/16
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Paracentesis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse effects

  Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Female and male Patients between 18-70 years with liver cirrhosis and ascites
• Indication for paracentesis

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Technische Universität Berlin: collaborator
• Humboldt-Universität zu Berlin: collaborator

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (4)

• 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.

  PMID: 9247479 RESULT

• 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.

  PMID: 15195901 RESULT

• 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.

  PMID: 8119542 RESULT

• 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.

  PMID: 12500206 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ascites fluid, serum and plasma probes

Study Officials

• Wiedenmann Betram, Prof. Dr. med.

  Charite Universitätsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 14, 2016
• Study Start: October 1, 2016
• Primary Completion: November 29, 2017
• Study Completion: June 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)