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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07751874
Acronym
CAT-RISK
Enrollment
50
Registered
2026-08-07
Start date
2026-10-15
Completion date
2028-07-01
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury, Regional citrate anticoagulation, citrate metabolism

Brief 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.

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.

Interventions

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

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of citrate intoxication96 hoursa. 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 intoxication96 hourscitrate intoxication and need for alternative anticoagulation regime

Countries

Belgium

Contacts

CONTACTwalter verbrugghe, MD
Walter.Verbrugghe@uza.be038214149
CONTACTRita Jacobs, MD
rita.jacobs2@uza.be038214795

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026