Acute Kidney InjuryCAT-RISKNCT07751874
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 of Acute Kidney Injury, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- continuous renal replacement therapy with regional citrate anticoagulation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients older than 18 years with acute kidney injury requiring continuous renal replacement therapy with reduced of absent citrate metabolism
Who may be able to join
- 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
Who cannot join
- Pregnancy
- A known hypersensitivity to citrate compounds
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Antwerp University Hospital
Edegem, Antwerp, 2650
Walter Verbrugghe, MD, 038214149 ext. +32, Walter.Verbrugghe@uza.be
Rita Jacobs, MD, 038214795 ext. +32, rita.jacobs2@uza.be
About this study
Official title: 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.
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.
- Conditions
- Acute Kidney Injury
- Being tested
- continuous renal replacement therapy with regional citrate anticoagulation
- Keywords
- Acute kidney injury, Regional citrate anticoagulation, citrate metabolism
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapy with regional citrate anticoagulationDevice
CVVHDF using regional citrate anticoagulation in patients with absent or reduced citrate metabolism
| Study group | Role | What they receive |
|---|---|---|
| Citrate group | Patients needing continuous renal replacement therapy with absent or reduced citrate metabolism treated with regional citrate anticoagulation Receives: Device: continuous renal replacement therapy with regional citrate anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of citrate intoxication
- 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
Measured: 96 hours
the incidence of refractory citrate intoxication
citrate intoxication and need for alternative anticoagulation regime
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Verbrugghe, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751874
- Sponsor's protocol ID
- B3002024000109
- Acronym
- CAT-RISK
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: sharing upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07751874
- Acronym / sponsor ID
- CAT-RISK / B3002024000109
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Regional citrate anticoagulation, citrate metabolism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Citrate group | – | Device: continuous renal replacement therapy with regional citrate anticoagulationPatients needing continuous renal replacement therapy with absent or reduced citrate metabolism treated with regional citrate anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients older than 18 years with acute kidney injury requiring continuous renal replacement therapy with reduced of absent citrate metabolism
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- A known hypersensitivity to citrate compounds
- Refusal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous renal replacement therapy with regional citrate anticoagulationCVVHDF using regional citrate anticoagulation in patients with absent or reduced citrate metabolism | Device | Citrate group |
Primary outcome
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 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
the incidence of refractory citrate intoxication
Time frame: 96 hours
citrate intoxication and need for alternative anticoagulation regime
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided. sharing upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact walter verbrugghe, MD (038214149 ext. +32, Walter.Verbrugghe@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of citrate intoxication (time frame: 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.