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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 paracentesis through 14 Gauge catheter
UCIP7 - Centro Hospitalar Universitário de Lisboa Central
Lisbon, Portugal
RECRUITINGRenal function - creatinine clearance
estimated and measured creatinine clearance (mL/min)
Time frame: intensive care stay up to 7 days
Renal function - urine output
measured urine output (mL/min)
Time frame: intensive care stay up to 7 days
Renal function - renal replacement therapy
number of renal replacement therapy days
Time frame: 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.
Time frame: intensive care stay up to 7 days
ICU Mortality rate
Mortality rate until discharge from the ICU
Time frame: from admission into the ICU up to 30 days onwards
in hospital Mortality rate
Mortality rate until discharge from hospital admission
Time frame: from admission into the ICU up to 60 days onwards
30 days Mortality rate
Mortality rate up to 30 days from ICU admission
Time frame: from admission into the ICU up to 30 days onwards
Emergent liver transplant rate
liver transplant rate up to 28 days after ICU admission
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Time frame: from admission into the ICU up to 28 days onwards