Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure/DysfuncTION, the CAUTION Trial! A Retrospective Study on Etiology of Liver Failure and Their Complications

NCT06908746 | Recruiting

• 2 other identifiers: Project ID 6806Edge 003873
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study design A retrospective cohort study will be conducted to compare the efficacy and safety of citrate anticoagulation in CRRT among patients with liver failure/dysfunction and severe shock. Objectives

1. 1.Primary Objective: To determine if the etiology of liver failure impacts the incidence of citrate-related complications in patients undergoing CRRT.
2. 2.Secondary Objectives: To compare the efficacy of citrate anticoagulation in terms of renal recovery, filter lifespan, and patient survival between those with liver failure/dysfunction and severe shock.

Conditions

Liver Failure; AKI - Acute Kidney Injury

Keywords

CRRT; liver failure; AKI

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint:

  Incidence of citrate-related metabolic complications (e.g., citrate accumulation).

  During admission at ICU

Secondary Outcomes (1)

• Secondary Safety Endpoints

  During admission at ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients diagnosed with AKI requiring CRRT

You may qualify if:

• Critically ill patients diagnosed with AKI requiring CRRT. Caution Protocol V1.0 24-07-2024
• Documented liver failure or significant liver dysfunction (e.g., elevated liver enzymes, bilirubin levels, or clinical diagnosis of liver failure) and clincal diagnosis of shock (NE of 0.25 μg/kg/min and or association of second vasopressor).
• Age ≥ 18 years.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (3)

• Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198.

  PMID: 37240843 BACKGROUND

• Mehta RL, McDonald BR, Aguilar MM, Ward DM. Regional citrate anticoagulation for continuous arteriovenous hemodialysis in critically ill patients. Kidney Int. 1990 Nov;38(5):976-81. doi: 10.1038/ki.1990.300. No abstract available.

  PMID: 2266683 BACKGROUND

• Kramer L, Bauer E, Joukhadar C, Strobl W, Gendo A, Madl C, Gangl A. Citrate pharmacokinetics and metabolism in cirrhotic and noncirrhotic critically ill patients. Crit Care Med. 2003 Oct;31(10):2450-5. doi: 10.1097/01.CCM.0000084871.76568.E6.

  PMID: 14530750 BACKGROUND

MeSH Terms

Conditions

Liver Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rita Jacobs, Dr.

  Antwerp Univesity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Jacobs, Dr.

CONTACT

+32 3 821 36 35; rita.jacobs2@uza.be

Petra Vertongen

CONTACT

+32 3 8214404; studies.inzo@uza.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: September 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)