ParacentesisParacentesisNCT02799160
Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
An observational study of Paracentesis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paracentesis
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2016to 1 Jun 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)
Who may be able to join
- Female and male Patients between 18-70 years with liver cirrhosis and ascites
- Indication for paracentesis
Who cannot join
- Infectious disease in the last 4 weeks
- Active alcohol-consumption or missing data of alcohol use
- Missing inform consent
- Missing speech comprehension
- Neurological or psychiatric disease that compromise consenting
- Hepatic encephalopathy stage III (West-Haven criteria)
Show all 10Show fewer
- Heart failure NYHA IV
- Renal insufficiency or hepatorenal syndrome
- Atrial fibrillation
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation
Read the detailed description
Ascites is one of the common complications in advanced liver cirrhosis. Large-volume paracentesis (LVP) is a widely used symptomatic intervention to remove large amounts of peritoneal fluid. Despite a low rate of interventional-associated complications like fistula or non life-threatening bleeding LVP induces an impairment of circulatory function. The hypothesis is that haemodynamic changes can be detected by non-invasive monitoring and that these haemodynamic changes could be associated to postinterventional organ dysfunction or complications. Additionally the investigators hypothesize that paracentesis-induced circulatory dysfunction could also be associated to present clinical and laboratory signs of inflammation or infection and could influenced by increased viable and non-viable bacterial translocation.
- Conditions
- Paracentesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time of stroke-volume (milliliter) before, under and after paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
Measured: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
Measured: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Secondary outcomes (1)
Incidence of adverse effects
Clinical, laboratory and haemodynamic adverse effects of paracentesis
Measured: Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start1 Oct 2016
- Primary completion29 Nov 2017
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ParacentesisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Berlin, Humboldt-Universität zu Berlin
- Responsible party
- Principal investigator, Dr. med. Donata Grajecki, Charite University, Berlin, Germany
- Investigators
- Wiedenmann Betram, Prof. Dr. med., Study director, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799160
- Sponsor's protocol ID
- EA2/052/16
- Acronym
- Paracentesis
- Status last verified
- Feb 2024
- First submitted
- 1 Jun 2016
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997 Aug;113(2):579-86. doi: 10.1053/gast.1997.v113.pm9247479.
PubMed 9247479Coll S, Vila MC, Molina L, Gimenez MD, Guarner C, Sola R. Mechanisms of early decrease in systemic vascular resistance after total paracentesis: influence of flow rate of ascites extraction. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):347-53. doi: 10.1097/00042737-200403000-00016.
PubMed 15195901Pozzi M, Osculati G, Boari G, Serboli P, Colombo P, Lambrughi C, De Ceglia S, Roffi L, Piperno A, Cusa EN, et al. Time course of circulatory and humoral effects of rapid total paracentesis in cirrhotic patients with tense, refractory ascites. Gastroenterology. 1994 Mar;106(3):709-19. doi: 10.1016/0016-5085(94)90706-4.
PubMed 8119542Albillos A, de la Hera A, Gonzalez M, Moya JL, Calleja JL, Monserrat J, Ruiz-del-Arbol L, Alvarez-Mon M. Increased lipopolysaccharide binding protein in cirrhotic patients with marked immune and hemodynamic derangement. Hepatology. 2003 Jan;37(1):208-17. doi: 10.1053/jhep.2003.50038.
PubMed 12500206
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
- ClinicalTrials.gov ID
- NCT02799160
- Acronym / sponsor ID
- Paracentesis / EA2/052/16
- Conditions
- Paracentesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Technische Universität Berlin, Humboldt-Universität zu Berlin
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 Jun 2016 (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.
This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation
Detailed description
Ascites is one of the common complications in advanced liver cirrhosis. Large-volume paracentesis (LVP) is a widely used symptomatic intervention to remove large amounts of peritoneal fluid. Despite a low rate of interventional-associated complications like fistula or non life-threatening bleeding LVP induces an impairment of circulatory function. The hypothesis is that haemodynamic changes can be detected by non-invasive monitoring and that these haemodynamic changes could be associated to postinterventional organ dysfunction or complications. Additionally the investigators hypothesize that paracentesis-induced circulatory dysfunction could also be associated to present clinical and laboratory signs of inflammation or infection and could influenced by increased viable and non-viable bacterial translocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)
Key inclusion criteria (2 listed)
- Female and male Patients between 18-70 years with liver cirrhosis and ascites
- Indication for paracentesis
Key exclusion criteria (10 listed)
- Infectious disease in the last 4 weeks
- Active alcohol-consumption or missing data of alcohol use
- Missing inform consent
- Missing speech comprehension
- Neurological or psychiatric disease that compromise consenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change over time of stroke-volume (milliliter) before, under and after paracentesis
Time frame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis
Time frame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
1 secondary outcome
Incidence of adverse effects
Time frame: Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 9247479Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997 Aug;113(2):579-86. doi: 10.1053/gast.1997.v113.pm9247479.
- Results publication: PubMed 15195901Coll S, Vila MC, Molina L, Gimenez MD, Guarner C, Sola R. Mechanisms of early decrease in systemic vascular resistance after total paracentesis: influence of flow rate of ascites extraction. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):347-53. doi: 10.1097/00042737-200403000-00016.
- Results publication: PubMed 8119542Pozzi M, Osculati G, Boari G, Serboli P, Colombo P, Lambrughi C, De Ceglia S, Roffi L, Piperno A, Cusa EN, et al. Time course of circulatory and humoral effects of rapid total paracentesis in cirrhotic patients with tense, refractory ascites. Gastroenterology. 1994 Mar;106(3):709-19. doi: 10.1016/0016-5085(94)90706-4.
- Results publication: PubMed 12500206Albillos A, de la Hera A, Gonzalez M, Moya JL, Calleja JL, Monserrat J, Ruiz-del-Arbol L, Alvarez-Mon M. Increased lipopolysaccharide binding protein in cirrhotic patients with marked immune and hemodynamic derangement. Hepatology. 2003 Jan;37(1):208-17. doi: 10.1053/jhep.2003.50038.
- Individual participant dataSharing planned: No
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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.
Wiedenmann Betram, Prof. Dr. med. study director
Charite Universitätsmedizin Berlin
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 Paracentesis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. 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 Germany. 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?
Results are not available in the source record.
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?
Change over time of stroke-volume (milliliter) before, under and after paracentesis (time frame: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799160, which also lists 4 linked publications.
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 13 Feb 2024.