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Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial

Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07751861
Acronym
LEON1
Enrollment
176
Registered
2026-08-07
Start date
2023-10-01
Completion date
2025-04-01
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

regional citrate anticoagulation, continuous kidney replacement therapy, metabolic complications, electrolyte disorders

Brief summary

This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.

Detailed description

This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.

Interventions

DEVICElow concentrated citrate solution (18 mmol/L)

use of a low concentrated citrate solution (18 mmol/L)

DEVICEhigh concentrated citrate solution (136 mmol/L)

high concentrated citrate solution (136 mmol/L)

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Any adult patient admitted to the intensive care unit with acute kidney injury requiring continuous kidney replacement therapy

Exclusion criteria

* expected duration of continuous kidney replacement therapy less than 96 hours * prior continuous kidney replacement therapy before inclusion * a known hypersensitivity to citrate, acute liver failure or liver cirrhosis Child-Pugh C * persistent severe hemodynamic shock with decreased lactate clearance * a high likelihood of dying within the first 24h after initiation of CKRT * preexisting severe electrolyte disorders before CKRT initiation not attributable to Acute kidney injury

Design outcomes

Primary

MeasureTime frameDescription
Need for additional electrolyte supplementation96 hoursNeed for additional electrolyte supplementation : magnesium, phosphate, potassium

Secondary

MeasureTime frameDescription
Time course of serum electrolyte concentrations96 hoursTime course of serum electrolyte concentrations
Incidence of electrolyte and acid-base disorders96 hoursIncidence of electrolyte and acid-base disorders

Countries

Belgium

Outcome results

None listed

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