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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01091233
• Other study ID #: 2009/722
• Status: Withdrawn
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Critical Illness
• Critically Ill
• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h 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.	24h after paracentesis
Secondary	The association between the change in IAP and kidney function		24h after paracentesis
Secondary	The relationship between the amount of fluid drained and any effect on IAP and kidney function		24h after paracentesis
Secondary	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

External Links

•   website University Hospital Ghent