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
NCT ID: NCT06908746
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-09-30
2025-12-31
Brief Summary
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Objectives
1. Primary Objective: To determine if the etiology of liver failure impacts the incidence of citrate-related complications in patients undergoing CRRT.
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.
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Detailed Description
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Citrate acts as an anticoagulant by chelating calcium, an essential cofactor in the coagulation cascade, thus preventing clot formation within the extracorporeal circuit2. The citrate-calcium complex is then metabolized mainly in the liver, where citrate is converted into bicarbonate, and calcium is released back into the bloodstream. This mechanism provides dual benefits: effective anticoagulation and metabolic alkalization.
Patients with liver failure present unique challenges for citrate anticoagulation. Impaired liver function can lead to the accumulation of citrate, resulting in high anion gap metabolic acidosis and hypocalcemia3. These risks underscore the need for vigilant monitoring and potential adjustment of citrate dosing in this population. The aim of the present study is to explore whether the etiology of liver failure, which can range from alcoholic liver disease to drug-induced liver injury or shock liver, influences the incidence and severity of citrate-related complications.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Principal Investigators
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Rita Jacobs, Dr.
Role: PRINCIPAL_INVESTIGATOR
Antwerp Univesity Hospital
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Edge 003873
Identifier Type: OTHER
Identifier Source: secondary_id
Project ID 6806
Identifier Type: -
Identifier Source: org_study_id
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