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Starting soon Observational

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

NCT07751874 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2026-10-15
Last updated
2026-09-21

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

continuous renal replacement therapy with regional citrate anticoagulation

continuous renal replacement therapy with regional citrate anticoagulation: CVVHDF using regional citrate anticoagulation in patients with absent or reduced citrate metabolism

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • the incidence of citrate intoxication — 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 — 96 hours
    citrate intoxication and need for alternative anticoagulation regime

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerp
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07751874 on ClinicalTrials.gov ↗ ← All trials in Belgium