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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Hemodynamic Changes During Paracentesis

NCT02996188

Tense Ascites Liver Cirrhosis

COMPLETED

Continuous Passive Paracentesis for Intra-abdominal Hypertension

NCT04322201

Ascites Hepatic Cirrhosis, Liver Hypertension, Intraabdominal +2 more

UNKNOWN NA

Intrarenal Venous Flow Change During Fluid Removal in Critically Ill Patients: A Prospective Exploratory Study

NCT06216119

Critical Illness Fluid Overload

COMPLETED

Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients

NCT01824771

Kidney Injury, Acute

COMPLETED

The Intensive Care Platform Trial

NCT06667999

Intensive Care Patients Intensive Care Unit Patients Critical Illness

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paracentesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No