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Continuous Passive Paracentesis for Intra-abdominal Hypertension (COPPTRIAHL)

Primary Purpose

Ascites Hepatic, Cirrhosis, Liver, Hypertension, Intraabdominal

Status

Unknown status

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

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

Ultrasound-guided intermittent large-volume paracentesis

About this trial

This is an interventional treatment trial for Ascites Hepatic focused on measuring Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UCIP7 - Centro Hospitalar Universitário de Lisboa CentralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group - Continuous passive paracentesis

Control group - Large volume paracentesis

Arm 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.

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

Outcomes

Primary Outcome Measures

Renal function - creatinine clearance

estimated and measured creatinine clearance (mL/min)

Renal function - urine output

measured urine output (mL/min)

Renal function - renal replacement therapy

number of renal replacement therapy days

Multi-organ disfunction

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

ICU Mortality rate

Mortality rate until discharge from the ICU

in hospital Mortality rate

Mortality rate until discharge from hospital admission

30 days Mortality rate

Mortality rate up to 30 days from ICU admission

Emergent liver transplant rate

liver transplant rate up to 28 days after ICU admission

Full Information

NCT ID

NCT04322201

First Posted

December 20, 2019

Last Updated

March 25, 2020

Sponsor

Centro Hospitalar de Lisboa Central

Collaborators

NOVA Medical School

1. Study Identification

Unique Protocol Identification Number

NCT04322201

Brief Title

Continuous Passive Paracentesis for Intra-abdominal Hypertension

Acronym

COPPTRIAHL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2, 2019 (Actual)

Primary Completion Date

November 30, 2021 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro Hospitalar de Lisboa Central

Collaborators

NOVA Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Hepatic Ascites, Liver Cirrhosis, Intraabdominal Hypertension, Paracentesis, Puncture and Drainage, Critical Illness, acute-on-chronic liver failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group - Continuous passive paracentesis

Arm Type

Experimental

Arm 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.

Arm Title

Control group - Large volume paracentesis

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

continuous passive paracentesis

Intervention 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

Intervention Type

Procedure

Intervention Name(s)

Ultrasound-guided intermittent large-volume paracentesis

Other Intervention Name(s)

intermittent passive paracentesis

Intervention Description

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

Primary Outcome Measure Information:

Title

Renal function - creatinine clearance

Description

estimated and measured creatinine clearance (mL/min)

Time Frame

intensive care stay up to 7 days

Title

Renal function - urine output

Description

measured urine output (mL/min)

Time Frame

intensive care stay up to 7 days

Title

Renal function - renal replacement therapy

Description

number of renal replacement therapy days

Time Frame

intensive care stay up to 7 days

Title

Multi-organ disfunction

Description

Time Frame

intensive care stay up to 7 days

Secondary Outcome Measure Information:

Title

ICU Mortality rate

Description

Mortality rate until discharge from the ICU

Time Frame

from admission into the ICU up to 30 days onwards

Title

in hospital Mortality rate

Description

Mortality rate until discharge from hospital admission

Time Frame

from admission into the ICU up to 60 days onwards

Title

30 days Mortality rate

Description

Mortality rate up to 30 days from ICU admission

Time Frame

from admission into the ICU up to 30 days onwards

Title

Emergent liver transplant rate

Description

liver transplant rate up to 28 days after ICU admission

Time Frame

from admission into the ICU up to 28 days onwards

Other Pre-specified Outcome Measures:

Title

ICU length-of-stay

Description

days in Intensive Care Unit

Time Frame

from admission into the ICU up to 28 days

Title

Hospital length-of-stay

Description

days of Hospital stay

Time Frame

from admission into the ICU up to 60 days onwards

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rui A Pereira, MD, MSc

Phone

+351 934341322

rui.m.pereira@chlc.min-saude.pt

First Name & Middle Initial & Last Name or Official Title & Degree

Luis Pereira-da-Silva, MD, PhD

Phone

213596402

Ext

51402

centro.investigacao@chlc.min-saude.pt

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rui A Pereira, MD, MSc

Organizational Affiliation

Centro Hospitalar de Lisboa Central

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCIP7 - Centro Hospitalar Universitário de Lisboa Central

City

Lisboa

ZIP/Postal Code

1050-099

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui A Pereira, MD, MSc

Phone

+351 934341322

rui.m.pereira@chlc.min-saude.pt

First Name & Middle Initial & Last Name & Degree

Rui A Pereira, MD, MSc

First Name & Middle Initial & Last Name & Degree

Nuno S Germano, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29904292

Citation

Caldwell J, Edriss H, Nugent K. Chronic peritoneal indwelling catheters for the management of malignant and nonmalignant ascites. Proc (Bayl Univ Med Cent). 2018 Jun 1;31(3):297-302. doi: 10.1080/08998280.2018.1461525. eCollection 2018 Jul.

Results Reference

background

PubMed Identifier

26056530

Citation

Kyoung KH, Hong SK. The duration of intra-abdominal hypertension strongly predicts outcomes for the critically ill surgical patients: a prospective observational study. World J Emerg Surg. 2015 May 30;10:22. doi: 10.1186/s13017-015-0016-7. eCollection 2015.

Results Reference

background

PubMed Identifier

23673399

Citation

Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.

Results Reference

background

PubMed Identifier

22873420

Citation

Al-Dorzi HM, Tamim HM, Rishu AH, Aljumah A, Arabi YM. Intra-abdominal pressure and abdominal perfusion pressure in cirrhotic patients with septic shock. Ann Intensive Care. 2012 Jul 5;2 Suppl 1(Suppl 1):S4. doi: 10.1186/2110-5820-2-S1-S4. Epub 2012 Jul 5.

Results Reference

result

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Continuous Passive Paracentesis for Intra-abdominal Hypertension

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