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NCT Number: NCT07751874

A Prospective, Observational Study to Evaluate the Safety and Feasibility of Continuous Renal Replacement Therapy With Regional Citrate Anticoagulation in a Cohort Critical Ill Patients With Acute Kidney Injury and Presumed Absent Citrate Metabolism

Use of regional citrate anticoagulation in an at risk population with decreased citrate metabolism. This study assesses the feasibility and safety of regional citrate anticoagulation in this population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location contact

Philippe Jorens, PhD

SUB_INVESTIGATOR

Rita Jacobs, MD

CONTACT

[email protected]

038214795 ext. +32

Symen Ligthart, PhD

SUB_INVESTIGATOR

Walter Verbrugghe, MD

CONTACT

[email protected]

038214149 ext. +32

About this study

Regional citrate anticoagulation (RCA) is the recommended anticoagulation strategy for continuous renal replacement therapy (CRRT). Traditionally, CRRT-RCA is not recommended in patients with advanced liver failure or in patients with severe hemodynamic shock due to the risk of citrate accumulation or citrate intoxication. However, since more than a decade more and more patients with advanced liver failure and severe hemodynamic shock undergo safely CRRT-RCA with an adapted CRRT protocol. The aim of this study is to evaluate the efficacy and safety of CRRT-RCA in patients with decreased citrate metabolism using an adapted protocol to maximize citrate elimination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Need for renal replacement therapy in the ICU with any of the following criteria:
  • anticipation of severely impaired citrate metabolism (serum lactate ≥ 5 mmol/l in patients with shock or requirement of a dextrose drip to prevent hypoglycemia or spontaneous INR > 3 and/or requirement of fresh frozen plasma to maintain INR < 3 in patients with cirrhosis or acute liver failure or acute on chronic liver failure)
  • development of citrate toxicity under CRRT with RCA due to worsening citrate metabolism

Exclusion criteria

  • Pregnancy
  • A known hypersensitivity to citrate compounds
  • Refusal of informed consent

Treatment and study plan

continuous renal replacement therapy with regional citrate anticoagulation

Device

CVVHDF using regional citrate anticoagulation in patients with absent or reduced citrate metabolism

Primary outcomes

  1. the incidence of citrate intoxication

    Time frame: 96 hours

    a. Citrate accumulation defined as a total/ionized calcium ratio > 2,5 b. Citrate intoxication is defined as i. Total/ionized calcium > 2,5 in combination with two of the following

    • Ionized calcium < 0,8 in spite of calcium substitution
    • Increasing demand in calcium substitution during the last 8 hours
    • Presence of high anion gap metabolic acidosis
  2. the incidence of refractory citrate intoxication

    Time frame: 96 hours

    citrate intoxication and need for alternative anticoagulation regime

Study contacts

Contact information is provided by the study sponsor or research team.

Rita Jacobs, MD

CONTACT

[email protected]

038214795 ext. +32

walter verbrugghe, MD

CONTACT

[email protected]

038214149 ext. +32

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Acronym: CAT-RISK

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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