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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01091233
Collaborator
(none)
0
1
33.1
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: paracentesis

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Paracentesis

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The association between the change in IAP and kidney function [24h after paracentesis]

  2. The relationship between the amount of fluid drained and any effect on IAP and kidney function [24h after paracentesis]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Ghent Ghent Belgium

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Eric Hoste, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01091233
Other Study ID Numbers:
  • 2009/722
First Posted:
Mar 23, 2010
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Keywords provided by University Hospital, Ghent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2021