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

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Charité University Medicine Berlin

Status

Active, not recruiting

Conditions

Paracentesis

Study type

Observational

Funder types

Other

Identifiers

NCT02799160
EA2/052/16

Details and patient eligibility

About

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

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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