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

NCT01091233 | Withdrawn

• 1 other identifier: 2009/722
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Liver Cirrhosis; Ascites

Keywords

Critically ill patients; liver cirrhosis; ascites requiring Paracentesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Paracentesis

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

Procedure: paracentesis

Interventions

paracentesis PROCEDURE

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

Paracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>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

You may not qualify if:

• Renal replacement therapy in place
• Urinary catheter contra-indicated
• Use of radiocontrast media within 72h before paracentesis

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent

MeSH Terms

Conditions

Critical Illness; Liver Cirrhosis; Ascites

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eric Hoste, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

BE (1)