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

NCT07751874 | Not Yet Recruiting

• 1 other identifier: B3002024000109
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Regional citrate anticoagulation; citrate metabolism

Outcome Measures

Primary Outcomes (2)

• 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

  96 hours

• the incidence of refractory citrate intoxication

  citrate intoxication and need for alternative anticoagulation regime

  96 hours

Study Arms (1)

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

continuous renal replacement therapy with regional citrate anticoagulation DEVICE

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

Citrate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

walter verbrugghe, MD

CONTACT

038214149; Walter.Verbrugghe@uza.be

Rita Jacobs, MD

CONTACT

038214795; rita.jacobs2@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

BE (1)