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

This study has suspended participant recruitment.
(logistical problems)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01091233
First received: March 19, 2010
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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 Intervention
Critically Ill
Liver Cirrhosis
Ascites
Procedure: paracentesis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis [ Time Frame: 24h after paracentesis ] [ Designated as safety issue: No ]
    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:
  • The association between the change in IAP and kidney function [ Time Frame: 24h after paracentesis ] [ Designated as safety issue: No ]
  • The relationship between the amount of fluid drained and any effect on IAP and kidney function [ Time Frame: 24h after paracentesis ] [ Designated as safety issue: No ]
  • Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites [ Time Frame: 24h after paracentesis ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091233

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Eric Hoste, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01091233     History of Changes
Other Study ID Numbers: 2009/722
Study First Received: March 19, 2010
Last Updated: July 19, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Critically ill patients
liver cirrhosis
ascites requiring Paracentesis

Additional relevant MeSH terms:
Liver Cirrhosis
Critical Illness
Ascites
Liver Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014