Continuous Passive Paracentesis for Intra-abdominal Hypertension

NCT04322201 | Unknown

• 1 other identifier: CHULC.CI.450.2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• ICU Mortality rate

  from admission into the ICU up to 30 days onwards

• in hospital Mortality rate

  from admission into the ICU up to 60 days onwards

• 30 days Mortality rate

  from admission into the ICU up to 30 days onwards

• Emergent liver transplant rate

  from admission into the ICU up to 28 days onwards

Other Outcomes (2)

• ICU length-of-stay

  from admission into the ICU up to 28 days

• Hospital length-of-stay

  from admission into the ICU up to 60 days onwards

Study Arms (2)

Intervention group - Continuous passive paracentesis

EXPERIMENTAL

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

Control group - Large volume paracentesis

ACTIVE COMPARATOR

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

Interventions

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

Also known as: continuous passive paracentesis

Intervention group - Continuous passive paracentesis

Ultrasound-guided intermittent large-volume paracentesis PROCEDURE

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

Also known as: intermittent passive paracentesis

Control group - Large volume paracentesis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• liver cirrhosis diagnosis with ascites
• ICU admission for medical reason

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead
• NOVA Medical School: collaborator

Study Sites (1)

UCIP7 - Centro Hospitalar Universitário de Lisboa Central

Lisbon, 1050-099, Portugal

RECRUITING

Related Publications (5)

• 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.

  PMID: 29904292 BACKGROUND

• 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.

  PMID: 26056530 BACKGROUND

• 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.

  PMID: 23673399 BACKGROUND

• 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.

  PMID: 22873420 RESULT

• Pereira RA, Virella D, Perdigoto R, Marcelino P, Saliba F, Germano N. Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL): study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):534. doi: 10.1186/s13063-023-07541-4.

  PMID: 37582719 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Intra-Abdominal Hypertension; Critical Illness; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Study Officials

• Rui A Pereira, MD, MSc

  Centro Hospitalar de Lisboa Central

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui A Pereira, MD, MSc

CONTACT

+351 934341322; rui.m.pereira@chlc.min-saude.pt

Luis Pereira-da-Silva, MD, PhD

CONTACT

213596402; centro.investigacao@chlc.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: March 26, 2020
• Study Start: November 2, 2019
• Primary Completion: November 30, 2021
• Study Completion: May 31, 2022
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)