Continuous Passive Paracentesis for Intra-abdominal Hypertension (COPPTRIAHL)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rui A Pereira, MD, MSc; Phone Number: +351 934341322; Email: rui.m.pereira@chlc.min-saude.pt
• Study Contact Backup: Name: Luis Pereira-da-Silva, MD, PhD; Phone Number: 51402 213596402; Email: centro.investigacao@chlc.min-saude.pt

Study Locations

• Portugal
  • Lisboa, Portugal, 1050-099
    • Recruiting
    • UCIP7 - Centro Hospitalar Universitário de Lisboa Central
    • Contact: Rui A Pereira, MD, MSc; Phone Number: +351 934341322; Email: rui.m.pereira@chlc.min-saude.pt
    • Principal Investigator: Rui A Pereira, MD, MSc
    • Sub-Investigator: Nuno S Germano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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; Other Names: continuous passive paracentesis
ACTIVE_COMPARATOR: 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.	Procedure: Ultrasound-guided intermittent large-volume paracentesis; Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter; Other Names: intermittent passive paracentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function - creatinine clearance	estimated and measured creatinine clearance (mL/min)	intensive care stay up to 7 days
Renal function - urine output	measured urine output (mL/min)	intensive care stay up to 7 days
Renal function - renal replacement therapy	number of renal replacement therapy days	intensive care stay up to 7 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.	intensive care stay up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Mortality rate	Mortality rate until discharge from the ICU	from admission into the ICU up to 30 days onwards
in hospital Mortality rate	Mortality rate until discharge from hospital admission	from admission into the ICU up to 60 days onwards
30 days Mortality rate	Mortality rate up to 30 days from ICU admission	from admission into the ICU up to 30 days onwards
Emergent liver transplant rate	liver transplant rate up to 28 days after ICU admission	from admission into the ICU up to 28 days onwards

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length-of-stay	days in Intensive Care Unit	from admission into the ICU up to 28 days
Hospital length-of-stay	days of Hospital stay	from admission into the ICU up to 60 days onwards

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Lisboa Central
• Collaborators: NOVA Medical School
• Investigators: Principal Investigator: Rui A Pereira, MD, MSc, Centro Hospitalar de Lisboa Central

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2019
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Critical Illness; Paracentesis; acute-on-chronic liver failure; Hepatic Ascites; Intraabdominal Hypertension; Puncture and Drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Liver Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Fibrosis; Hypertension; Liver Cirrhosis; Ascites; Critical Illness; Intra-Abdominal Hypertension
• Other Study ID Numbers: CHULC.CI.450.2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No