Continuous Passive Paracentesis for Intra-abdominal Hypertension

Not Applicable

• Conditions: Critical Illness; Cirrhosis, Liver; Paracentesis; Ascites Hepatic; Hypertension, Intraabdominal

• Registration Number: NCT04322201
• Lead Sponsor: Centro Hospitalar de Lisboa Central

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.

Study Timeline

• Study Start: 2019-11-02
• Study First Submitted: 2019-12-20
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-25
• Last Update Submitted: 2020-03-25
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26
• Primary Completion: 2021-11-30
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
30 days Mortality rate	from admission into the ICU up to 30 days onwards	Mortality rate up to 30 days from ICU admission
ICU Mortality rate	from admission into the ICU up to 30 days onwards	Mortality rate until discharge from the ICU
Emergent liver transplant rate	from admission into the ICU up to 28 days onwards	liver transplant rate up to 28 days after ICU admission
in hospital Mortality rate	from admission into the ICU up to 60 days onwards	Mortality rate until discharge from hospital admission

Trial Locations

Locations (1)

UCIP7 - Centro Hospitalar Universitário de Lisboa Central; 🇵🇹 Lisboa, Portugal