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Not yet recruitingNCT07751874CAT-RISKUpdated Sep 21, 2026

A 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

An observational study in Acute Kidney Injury, sponsored by University Hospital, Antwerp. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Acute Kidney Injury

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Keywords

  • Acute kidney injury
  • Regional citrate anticoagulation
  • citrate metabolism
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In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients older than 18 years with acute kidney injury requiring continuous renal replacement therapy with reduced of absent citrate metabolism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 > 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

Exclusion Criteria:

  • Pregnancy
  • A known to citrate compounds
  • Refusal of
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Citrate group

    Patients needing continuous renal replacement therapy with absent or reduced citrate metabolism treated with regional citrate anticoagulation

    Device: continuous renal replacement therapy with regional citrate anticoagulation

Interventions

  • Devicecontinuous renal replacement therapy with regional citrate anticoagulation

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

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What researchers measure

Primary outcomes

  1. the incidence of citrate intoxication

    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 1. Ionized calcium \< 0,8 in spite of calcium substitution 2. Increasing demand in calcium substitution during the last 8 hours 3. Presence of high anion gap metabolic acidosis

    Time frame: 96 hours

  2. the incidence of refractory citrate intoxication

    citrate intoxication and need for alternative anticoagulation regime

    Time frame: 96 hours

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided — sharing upon reasonable request

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07751874
Responsible party
Walter Verbrugghe (Principal Investigator, University Hospital, Antwerp) — Principal investigator
First posted
Aug 7, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

walter verbrugghe, MD
Contact
Walter.Verbrugghe@uza.be
038214149 ext. +32
Rita Jacobs, MD
Contact
rita.jacobs2@uza.be
038214795 ext. +32

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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