Critically IllNCT01091233
The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study
An observational study of Critically Ill and Liver Cirrhosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Liver Cirrhosis, Ascites
- What is being tested?
- paracentesis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician
Who may be able to join
- >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
Who cannot join
- Previous inclusion in the same study
- Renal replacement therapy in place
- Urinary catheter contra-indicated
- Use of radiocontrast media within 72h before paracentesis
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- paracentesis
- Keywords
- Critically ill patients, liver cirrhosis, ascites requiring Paracentesis
- Medical subject headings
- Critical Illness, Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracentesisProcedure or surgery
as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)
| Study group | Role | What they receive |
|---|---|---|
| Paracentesis | Paracentesis as indicated according to the treating physician (the indication for Paracentesis is not the subject of study) Receives: Procedure: paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24h after paracentesis
Secondary outcomes (3)
The association between the change in IAP and kidney function
Measured: 24h after paracentesis
The relationship between the amount of fluid drained and any effect on IAP and kidney function
Measured: 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
Measured: 24h after paracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hoste, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091233
- Sponsor's protocol ID
- 2009/722
- Status last verified
- Jul 2021
- First submitted
- 19 Mar 2010
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01091233
- Acronym / sponsor ID
- 2009/722
- Conditions
- Critically Ill, Liver Cirrhosis, Ascites
- Keywords
- Critically ill patients, liver cirrhosis, ascites requiring Paracentesis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paracentesis | – | Procedure: paracentesisParacentesis as indicated according to the treating physician (the indication for Paracentesis is not the subject of study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (4 listed)
- Previous inclusion in the same study
- Renal replacement therapy in place
- Urinary catheter contra-indicated
- Use of radiocontrast media within 72h before paracentesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracentesisas indicated according to the treating physician (the indication for Paracentesis is not the subject of study) | Procedure or surgery | Paracentesis |
Primary outcome
Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis
Time frame: 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.
3 secondary outcomes
The association between the change in IAP and kidney function
Time frame: 24h after paracentesis
The relationship between the amount of fluid drained and any effect on IAP and kidney function
Time frame: 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
Time frame: 24h after paracentesis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hoste, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Liver Cirrhosis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis (time frame: 24h after paracentesis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.