Continuous Passive Paracentesis for Intra-abdominal Hypertension

Critical Illness Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322201
• Other study ID #: CHULC.CI.450.2019
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2020
• Source: Centro Hospitalar de Lisboa Central
• Contact: Rui A Pereira, MD, MSc
• Phone: +351 934341322
• Email: rui.m.pereira[@]chlc.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Cirrhosis, Liver
• Critical Illness
• Fibrosis
• Hypertension
• Hypertension, Intraabdominal
• Intra-Abdominal Hypertension
• Liver Cirrhosis
• Paracentesis

Intervention

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

Locations

Country	Name	City	State
Portugal	UCIP7 - Centro Hospitalar Universitário de Lisboa Central	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar de Lisboa Central	NOVA Medical School

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

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:S4. doi: 10.1186/2110-5820-2-S1-S4. Epub 2012 Jul 5. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU length-of-stay	days in Intensive Care Unit	from admission into the ICU up to 28 days
Other	Hospital length-of-stay	days of Hospital stay	from admission into the ICU up to 60 days onwards
Primary	Renal function - creatinine clearance	estimated and measured creatinine clearance (mL/min)	intensive care stay up to 7 days
Primary	Renal function - urine output	measured urine output (mL/min)	intensive care stay up to 7 days
Primary	Renal function - renal replacement therapy	number of renal replacement therapy days	intensive care stay up to 7 days
Primary	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	ICU Mortality rate	Mortality rate until discharge from the ICU	from admission into the ICU up to 30 days onwards
Secondary	in hospital Mortality rate	Mortality rate until discharge from hospital admission	from admission into the ICU up to 60 days onwards
Secondary	30 days Mortality rate	Mortality rate up to 30 days from ICU admission	from admission into the ICU up to 30 days onwards
Secondary	Emergent liver transplant rate	liver transplant rate up to 28 days after ICU admission	from admission into the ICU up to 28 days onwards