The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

NCT ID: NCT01091233

Last Updated: 2021-07-08

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

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.

Detailed Description

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Conditions

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Critically Ill Liver Cirrhosis Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paracentesis

Paracentesis as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)

paracentesis

Intervention Type PROCEDURE

as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)

Interventions

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paracentesis

as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \>18 y old
* Admitted to the ICU
* Known liver cirrhosis with ascites on clinical examination and/or ultrasound
* Sedated and mechanically ventilated
* Paracentesis deemed necessary by treating physician
* Arterial and central venous catheter in place
* Urinary catheter in place

Exclusion Criteria

* Previous inclusion in the same study
* Renal replacement therapy in place
* Urinary catheter contra-indicated
* Use of radiocontrast media within 72h before paracentesis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Hoste, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website University Hospital Ghent

Other Identifiers

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2009/722

Identifier Type: -

Identifier Source: org_study_id

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