Clinical trial NCT01091233: The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Critically Ill
Liver Cirrhosis
Ascites
Keywords: Critically ill patients
liver cirrhosis
ascites requiring Paracentesis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis
timeFrame: 24h after paracentesis
Secondary outcomes:
measure: The association between the change in IAP and kidney function
timeFrame: 24h after paracentesis
measure: The relationship between the amount of fluid drained and any effect on IAP and kidney function
timeFrame: 24h after paracentesis
measure: Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites
timeFrame: 24h after paracentesis
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Eric Hoste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: