Ascites Hepatic, Cirrhosis, Liver, Critical Illness, Hypertension, Intraabdominal, Paracentesis
Conditions
Keywords
Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure
Brief 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 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.
Interventions
DEVICEcontinuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter
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
PROCEDUREUltrasound-guided intermittent large-volume paracentesis
Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter
Sponsors
NOVA Medical School
Centro Hospitalar de Lisboa Central
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multi-organ disfunction | 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. |
| Renal function - renal replacement therapy | intensive care stay up to 7 days | number of renal replacement therapy days |
| Renal function - creatinine clearance | intensive care stay up to 7 days | estimated and measured creatinine clearance (mL/min) |
| Renal function - urine output | intensive care stay up to 7 days | measured urine output (mL/min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergent liver transplant rate | from admission into the ICU up to 28 days onwards | liver transplant rate up to 28 days after ICU admission |
| ICU Mortality rate | from admission into the ICU up to 30 days onwards | Mortality rate until discharge from the ICU |
| in hospital Mortality rate | from admission into the ICU up to 60 days onwards | Mortality rate until discharge from hospital admission |
| 30 days Mortality rate | from admission into the ICU up to 30 days onwards | Mortality rate up to 30 days from ICU admission |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU length-of-stay | from admission into the ICU up to 28 days | days in Intensive Care Unit |
| Hospital length-of-stay | from admission into the ICU up to 60 days onwards | days of Hospital stay |
Countries
Portugal
Contacts
Primary ContactRui A Pereira, MD, MSc
Backup ContactLuis Pereira-da-Silva, MD, PhD
Outcome results
None listed