Continuous Passive Paracentesis for Intra-abdominal Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ascites Hepatic, Cirrhosis, Liver, Hypertension, Intraabdominal, Critical Illness, Paracentesis

Intervention / Treatment
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* Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter
* Procedure: Ultrasound-guided intermittent large-volume paracentesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: liver cirrhosis diagnosis with ascites ICU admission for medical reason Exclusion Criteria: 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: i. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - Continuous passive paracentesis<br>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. | Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter<br>* 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<br>* Other names: continuous passive paracentesis;|
| Active Comparator: Control group - Large volume paracentesis<br>Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter performed and repeated during ICU stay according to standard-of-care clinical practice. | Procedure: Ultrasound-guided intermittent large-volume paracentesis<br>* Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter<br>* Other names: intermittent passive paracentesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function - creatinine clearance | estimated and measured creatinine clearance (mL/min) | intensive care stay up to 7 days | 
| Renal function - urine output | measured urine output (mL/min) | intensive care stay up to 7 days | 
| Renal function - renal replacement therapy | number of renal replacement therapy days | 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. | intensive care stay up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality rate | Mortality rate until discharge from the ICU | from admission into the ICU up to 30 days onwards | 
| in hospital Mortality rate | Mortality rate until discharge from hospital admission | from admission into the ICU up to 60 days onwards | 
| 30 days Mortality rate | Mortality rate up to 30 days from ICU admission | from admission into the ICU up to 30 days onwards | 
| Emergent liver transplant rate | liver transplant rate up to 28 days after ICU admission | from admission into the ICU up to 28 days onwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure