COPPTRIAHL: Continuous Passive Paracentesis for Intra-abdominal Hypertension
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group - 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. |
Device: continuous 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
Other Names:
|
| Active Comparator: Control group - Large volume paracentesis 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
Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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)
- Renal function - renal replacement therapy [intensive care stay up to 7 days]
number of renal replacement therapy days
- 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.
Secondary Outcome Measures
- 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
- Emergent liver transplant rate [from admission into the ICU up to 28 days onwards]
liver transplant rate up to 28 days after ICU admission
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
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:
- Hemorrhagic shock with active uncontrolled bleeding ii. Refractory shock (MAP<60mmHg) with multiple vasopressors iii. Predictably short ICU stay (<72 hours)
- Therapeutic futility determined by the medical staff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCIP7 - Centro Hospitalar Universitário de Lisboa Central | Lisboa | Portugal | 1050-099 |
Sponsors and Collaborators
- Centro Hospitalar de Lisboa Central
- NOVA Medical School
Investigators
- Principal Investigator: Rui A Pereira, MD, MSc, Centro Hospitalar de Lisboa Central
Study Documents (Full-Text)
None provided.More Information
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. Review.
- 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.
- 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.
- CHULC.CI.450.2019