Ascites HepaticCOPPTRIAHLNCT04322201
Continuous Passive Paracentesis for Intra-abdominal Hypertension
A study testing continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter and Ultrasound-guided intermittent large-volume paracentesis in people with Ascites Hepatic and Cirrhosis, Liver, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial summary
Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality. Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ascites Hepatic, Cirrhosis, Liver, Hypertension, Intraabdominal
- What is being tested?
- continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter and Ultrasound-guided intermittent large-volume paracentesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Nov 2019to 31 May 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis diagnosis with ascites
- ICU admission for medical reason
Who cannot join
- prior liver transplant
- haemorrhagic ascites
- extreme severity: CLIF-SOFA number of organ failures 5 or more
- less than 24 hours of ICU stay
- Any of the following conditions at 24 hours of ICU stay:
- Hemorrhagic shock with active uncontrolled bleeding ii. Refractory shock (MAP<60mmHg) with multiple vasopressors iii. Predictably short ICU stay (<72 hours) iv. Therapeutic futility determined by the medical staff
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
UCIP7 - Centro Hospitalar Universitário de Lisboa Central
Lisbon, 1050-099
Rui A Pereira, MD, MSc, +351 934341322, rui.m.pereira@chlc.min-saude.pt
Rui A Pereira, MD, MSc
About this study
Official title: Continuous Passive Paracentesis Versus Large Volume Paracentesis in the Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome in the Critically Ill Cirrhotic Patient With Ascites
Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality.
Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.
Read the detailed description
Intra-abdominal hypertension is an independent risk factors for increased mortality in Intensive Care patients and is highly prevalent in the critically ill cirrhotic patient. This study compares two strategies in minimizing intra-abdominal pressure and optimizing abdominal perfusion pressure in the prevention and treatment of intra-abdominal hypertension associated morbidity and mortality. Critically ill cirrhotic patients will be allocated into a standard-of-care large-volume paracentesis group (control) and a continuous passive paracentesis (intervention) group using randomization. Results will assess renal function and multi-organ function using standard clinical scales and vital outcomes.
- Conditions
- Ascites Hepatic, Cirrhosis, Liver, Hypertension, Intraabdominal, Critical Illness, Paracentesis
- Being tested
- continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter, Ultrasound-guided intermittent large-volume paracentesis
- Keywords
- Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure
- Medical subject headings
- Liver Cirrhosis, Intra-Abdominal Hypertension, Critical Illness, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheterDevice
Also called continuous passive paracentesis
Ultrasound-guided placement of an intra-abdominal double lumen central venous catheter, using aseptic Seldinger technique, for continuous drainage of ascitic fluid up to 7 days in Intensive Care
Ultrasound-guided intermittent large-volume paracentesisProcedure or surgery
Also called intermittent passive paracentesis
Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - Continuous passive paracentesis | Experimental | Ultrasound-guided placement of an intra-abdominal double lumen central venous catheter, using aseptic Seldinger technique, for continuous drainage of ascitic fluid up to 7 days in Intensive Care. Receives: Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter |
| Control group - Large volume paracentesis | Active comparator | Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter performed and repeated during ICU stay according to standard-of-care clinical practice. Receives: Procedure: Ultrasound-guided intermittent large-volume paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function - creatinine clearance
estimated and measured creatinine clearance (mL/min)
Measured: intensive care stay up to 7 days
Renal function - urine output
measured urine output (mL/min)
Measured: intensive care stay up to 7 days
Renal function - renal replacement therapy
number of renal replacement therapy days
Measured: intensive care stay up to 7 days
Multi-organ disfunction
Clinical multi-organ disfunction as assessed by severity scores: Sequencial Organ Failure Assessement (SOFA) and Chronic Liver Failure-SOFA (CLIF-SOFA). Both scores range [0-24] and higher scores reflect more severe organ dysfunctions and worse outcomes.
Measured: intensive care stay up to 7 days
Secondary outcomes (4)
ICU Mortality rate
Mortality rate until discharge from the ICU
Measured: from admission into the ICU up to 30 days onwards
in hospital Mortality rate
Mortality rate until discharge from hospital admission
Measured: from admission into the ICU up to 60 days onwards
30 days Mortality rate
Mortality rate up to 30 days from ICU admission
Measured: from admission into the ICU up to 30 days onwards
Emergent liver transplant rate
liver transplant rate up to 28 days after ICU admission
Measured: from admission into the ICU up to 28 days onwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start2 Nov 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ascites HepaticStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School
- Responsible party
- Sponsor
- Investigators
- Rui A Pereira, MD, MSc, Principal investigator, Centro Hospitalar de Lisboa Central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322201
- Sponsor's protocol ID
- CHULC.CI.450.2019
- Acronym
- COPPTRIAHL
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caldwell J, Edriss H, Nugent K. Chronic peritoneal indwelling catheters for the management of malignant and nonmalignant ascites. Proc (Bayl Univ Med Cent). 2018 Jun 1;31(3):297-302. doi: 10.1080/08998280.2018.1461525. eCollection 2018 Jul.
PubMed 29904292Kyoung KH, Hong SK. The duration of intra-abdominal hypertension strongly predicts outcomes for the critically ill surgical patients: a prospective observational study. World J Emerg Surg. 2015 May 30;10:22. doi: 10.1186/s13017-015-0016-7. eCollection 2015.
PubMed 26056530Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
PubMed 23673399Al-Dorzi HM, Tamim HM, Rishu AH, Aljumah A, Arabi YM. Intra-abdominal pressure and abdominal perfusion pressure in cirrhotic patients with septic shock. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S4. doi: 10.1186/2110-5820-2-S1-S4. Epub 2012 Jul 5.
PubMed 22873420Pereira RA, Virella D, Perdigoto R, Marcelino P, Saliba F, Germano N. Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL): study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):534. doi: 10.1186/s13063-023-07541-4.
PubMed 37582719
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Passive Paracentesis Versus Large Volume Paracentesis in the Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome in the Critically Ill Cirrhotic Patient With Ascites
- ClinicalTrials.gov ID
- NCT04322201
- Acronym / sponsor ID
- COPPTRIAHL / CHULC.CI.450.2019
- Conditions
- Ascites Hepatic, Cirrhosis, Liver, Hypertension, Intraabdominal, Critical Illness, Paracentesis
- Keywords
- Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Collaborators
- NOVA Medical School
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 26 Mar 2020 (actual)
- 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.
Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality.
Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.
Detailed description
Intra-abdominal hypertension is an independent risk factors for increased mortality in Intensive Care patients and is highly prevalent in the critically ill cirrhotic patient. This study compares two strategies in minimizing intra-abdominal pressure and optimizing abdominal perfusion pressure in the prevention and treatment of intra-abdominal hypertension associated morbidity and mortality. Critically ill cirrhotic patients will be allocated into a standard-of-care large-volume paracentesis group (control) and a continuous passive paracentesis (intervention) group using randomization. Results will assess renal function and multi-organ function using standard clinical scales and vital outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - Continuous passive paracentesis | Experimental | Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheterUltrasound-guided placement of an intra-abdominal double lumen central venous catheter, using aseptic Seldinger technique, for continuous drainage of ascitic fluid up to 7 days in Intensive Care. |
| Control group - Large volume paracentesis | Active comparator | Procedure: Ultrasound-guided intermittent large-volume paracentesisUltrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter performed and repeated during ICU stay according to standard-of-care clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- liver cirrhosis diagnosis with ascites
- ICU admission for medical reason
Key exclusion criteria (6 listed)
- prior liver transplant
- haemorrhagic ascites
- extreme severity: CLIF-SOFA number of organ failures 5 or more
- less than 24 hours of ICU stay
- Any of the following conditions at 24 hours of ICU stay:
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 |
|---|---|---|
| continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheterAlso: continuous passive paracentesisUltrasound-guided placement of an intra-abdominal double lumen central venous catheter, using aseptic Seldinger technique, for continuous drainage of ascitic fluid up to 7 days in Intensive Care | Device | Intervention group - Continuous passive paracentesis |
| Ultrasound-guided intermittent large-volume paracentesisAlso: intermittent passive paracentesisUltrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter | Procedure or surgery | Control group - Large volume paracentesis |
Primary outcome
Renal function - creatinine clearance
Time frame: intensive care stay up to 7 days
estimated and measured creatinine clearance (mL/min)
Renal function - urine output
Time frame: intensive care stay up to 7 days
measured urine output (mL/min)
Renal function - renal replacement therapy
Time frame: intensive care stay up to 7 days
number of renal replacement therapy days
Multi-organ disfunction
Time frame: intensive care stay up to 7 days
Clinical multi-organ disfunction as assessed by severity scores: Sequencial Organ Failure Assessement (SOFA) and Chronic Liver Failure-SOFA (CLIF-SOFA). Both scores range [0-24] and higher scores reflect more severe organ dysfunctions and worse outcomes.
4 secondary outcomes
ICU Mortality rate
Time frame: from admission into the ICU up to 30 days onwards
in hospital Mortality rate
Time frame: from admission into the ICU up to 60 days onwards
30 days Mortality rate
Time frame: from admission into the ICU up to 30 days onwards
Emergent liver transplant rate
Time frame: from admission into the ICU up to 28 days onwards
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 29904292Caldwell J, Edriss H, Nugent K. Chronic peritoneal indwelling catheters for the management of malignant and nonmalignant ascites. Proc (Bayl Univ Med Cent). 2018 Jun 1;31(3):297-302. doi: 10.1080/08998280.2018.1461525. eCollection 2018 Jul.
- Background: PubMed 26056530Kyoung KH, Hong SK. The duration of intra-abdominal hypertension strongly predicts outcomes for the critically ill surgical patients: a prospective observational study. World J Emerg Surg. 2015 May 30;10:22. doi: 10.1186/s13017-015-0016-7. eCollection 2015.
- Background: PubMed 23673399Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
- Results publication: PubMed 22873420Al-Dorzi HM, Tamim HM, Rishu AH, Aljumah A, Arabi YM. Intra-abdominal pressure and abdominal perfusion pressure in cirrhotic patients with septic shock. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S4. doi: 10.1186/2110-5820-2-S1-S4. Epub 2012 Jul 5.
- Derived from this study: PubMed 37582719Pereira RA, Virella D, Perdigoto R, Marcelino P, Saliba F, Germano N. Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL): study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):534. doi: 10.1186/s13063-023-07541-4.
- 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.
Rui A Pereira, MD, MSc principal investigator
Centro Hospitalar de Lisboa Central
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter and Ultrasound-guided intermittent large-volume paracentesis in people with Ascites Hepatic and Cirrhosis, Liver, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
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 6 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 26 Mar 2020. 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 Portugal. 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?
Contact Rui A Pereira, MD, MSc (+351 934341322, rui.m.pereira@chlc.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function - creatinine clearance (time frame: intensive care stay up to 7 days). The study lists 4 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 NCT04322201, which also lists 5 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 26 Mar 2020.