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

Withdrawn

• Conditions: Critically Ill; Liver Cirrhosis; Ascites
• Interventions: Procedure: paracentesis

• Registration Number: NCT01091233
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis	24h after paracentesis	Kidney function parameters include 2h creatinine clearance, serum and urine creatinine, renal artery resistive index (measured via color Doppler), urinary output, serum cystatine C and NGAL measurement.

Secondary Outcome Measures

Name	Time	Method
The association between the change in IAP and kidney function	24h after paracentesis
The relationship between the amount of fluid drained and any effect on IAP and kidney function	24h after paracentesis
Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites	24h after paracentesis

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium