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| Name | Class |
|---|---|
| NOVA Medical School | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter | Device | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length-of-stay | days in Intensive Care Unit | from admission into the ICU up to 28 days |
| Hospital length-of-stay | days of Hospital stay | from admission into the ICU up to 60 days onwards |
Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui A Pereira, MD, MSc | Contact | +351 934341322 | rui.m.pereira@chlc.min-saude.pt | |
| Luis Pereira-da-Silva, MD, PhD | Contact | 213596402 | 51402 | centro.investigacao@chlc.min-saude.pt |
| Name | Affiliation | Role |
|---|---|---|
| Rui A Pereira, MD, MSc | Centro Hospitalar de Lisboa Central | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCIP7 - Centro Hospitalar Universitário de Lisboa Central | Recruiting | Lisbon | 1050-099 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29904292 | Background | 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. | |
| 26056530 | Background | Kyoung 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. |
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|
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| Ultrasound-guided intermittent large-volume paracentesis | Procedure | Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter |
|
|
| 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 |
| 23673399 | Background | Kirkpatrick 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. |
| 22873420 | Result | Al-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. |
| 37582719 | Derived | Pereira 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. |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D059325 | Intra-Abdominal Hypertension |
| D016638 | Critical Illness |
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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