Continuous Passive Paracentesis for Intra-abdominal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-02

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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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

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Ascites Hepatic Cirrhosis, Liver Hypertension, Intraabdominal Critical Illness Paracentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group - Continuous passive paracentesis

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Control group - 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.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided intermittent large-volume paracentesis

Intervention Type PROCEDURE

Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter

Interventions

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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

Intervention Type DEVICE

Ultrasound-guided intermittent large-volume paracentesis

Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter

Intervention Type PROCEDURE

Other Intervention Names

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continuous passive paracentesis intermittent passive paracentesis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No