Clinical trial NCT04322201: Continuous Passive Paracentesis for Intra-abdominal Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ascites Hepatic
Cirrhosis, Liver
Hypertension, Intraabdominal
Critical Illness
Paracentesis
Keywords: Hepatic Ascites
Liver Cirrhosis
Intraabdominal Hypertension
Paracentesis
Puncture and Drainage
Critical Illness
acute-on-chronic liver failure
Lead sponsor: Centro Hospitalar de Lisboa Central
Sponsor class: OTHER
Collaborators: name: NOVA Medical School
First posted: 2020-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

  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

Primary outcomes:
measure: Renal function - creatinine clearance
timeFrame: intensive care stay up to 7 days
measure: Renal function - urine output
timeFrame: intensive care stay up to 7 days
measure: Renal function - renal replacement therapy
timeFrame: intensive care stay up to 7 days
measure: Multi-organ disfunction
timeFrame: intensive care stay up to 7 days
Secondary outcomes:
measure: ICU Mortality rate
timeFrame: from admission into the ICU up to 30 days onwards
measure: in hospital Mortality rate
timeFrame: from admission into the ICU up to 60 days onwards
measure: 30 days Mortality rate
timeFrame: from admission into the ICU up to 30 days onwards
measure: Emergent liver transplant rate
timeFrame: from admission into the ICU up to 28 days onwards
Other outcomes:
measure: ICU length-of-stay
timeFrame: from admission into the ICU up to 28 days
measure: Hospital length-of-stay
timeFrame: from admission into the ICU up to 60 days onwards
Locations:
city: Lisboa
country: Portugal
facility: UCIP7 - Centro Hospitalar Universitário de Lisboa Central
Study officials:
affiliation: Centro Hospitalar de Lisboa Central
name: Rui A Pereira, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.