Continuous Passive Paracentesis for Intra-abdominal Hypertension (COPPTRIAHL)

Centro Hospitalar de Lisboa Central

Status: Unknown

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

Treatments: Procedure: Ultrasound-guided intermittent large-volume paracentesis; Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04322201

CHULC.CI.450.2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention group - Continuous passive paracentesis

Experimental group

Description:

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.

Treatment:

Device: continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter

Control group - Large volume paracentesis

Active Comparator group

Description:

Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter performed and repeated during ICU stay according to standard-of-care clinical practice.

Treatment:

Procedure: Ultrasound-guided intermittent large-volume paracentesis