Continuous Passive Paracentesis for Intra-abdominal Hypertension

Not Applicable

• Conditions: Critical Illness; Cirrhosis, Liver; Paracentesis; Ascites Hepatic; Hypertension, Intraabdominal
• Interventions: Procedure: Ultrasound-guided intermittent large-volume paracentesis; Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter

• 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

Arm && Interventions

Group	Intervention	Description
Control group - Large volume paracentesis	Ultrasound-guided intermittent 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.
Intervention group - Continuous passive paracentesis	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.

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
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
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

Trial Locations

Locations (1)

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