NCT04322201

Continuous Passive Paracentesis for Intra-abdominal Hypertension

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centro Hospitalar de Lisboa Central · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascites Hepatic
• Cirrhosis, Liver
• Hypertension, Intraabdominal
• Critical Illness
• Paracentesis

Interventions

Type	Name	Description
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
PROCEDURE	Ultrasound-guided intermittent large-volume paracentesis	Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter

Timeline

• Start date: 2019-11-02
• Primary completion: 2021-11-30
• Completion: 2022-05-31
• First posted: 2020-03-26
• Last updated: 2020-03-26

Locations

1 site across 1 country: Portugal