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

Study Overview
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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.

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

Conditions
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Critically Ill, Liver Cirrhosis, Ascites

Intervention / Treatment
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* Procedure: paracentesis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paracentesis<br>Paracentesis as indicated according to the treating physician (the indication for Paracentesis is not the subject of study) | Procedure: paracentesis<br>* as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critically ill patients, liver cirrhosis, ascites requiring Paracentesis