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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: continuous renal replacement therapy with regional citrate anticoagulation.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device continuous renal replacement therapy with regional citrate anticoagulation
CVVHDF using regional citrate anticoagulation in patients with absent or reduced citrate metabolism
Primary outcome measures
- the incidence of citrate intoxication [Time frame: 96 hours]
- the incidence of refractory citrate intoxication [Time frame: 96 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Antwerp University Hospital — Edegem
Identifiers
NCT: NCT07751874 · B3002024000109