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Completed

NCT Number: NCT07751861

Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy.

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low concentrated citrate solution (18 mmol/L)

Device

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

high concentrated citrate solution (136 mmol/L)

Device

high concentrated citrate solution (136 mmol/L)

Primary outcomes

  1. Need for additional electrolyte supplementation

    Time frame: 96 hours

    Need for additional electrolyte supplementation : magnesium, phosphate, potassium expressed in grams of mmol during the 96 hour study period.

Secondary outcomes

  1. Time course of serum electrolyte concentrations

    Time frame: 96 hours

    Evolution of the serum electrolytes concentrations (potassium, magnesium, phosphorus, sodium, total calcium, ionized calcium, pH, bicarbonate) during the 96 hour study period for each arm.

  2. Incidence of electrolyte and acid-base disorders

    Time frame: 96 hours

    Cumulative incidence of electrolyte and acid-base disorders (hyponatremia, hypernatremia, hypomagnesemia, hypophophatemia, hypokalemia, metabolic alkalosis, metabolic acidosis) in each arm during the 96 hour study period

Other outcomes

  1. nurse's workload

    Time frame: 96 hours

    nurse's workload assessed by the number of separate electrolyte administrations

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: LEON1

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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