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OpenTrials
Completed

NCT Number: NCT04959110

Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Citrate has been proposed as anticoagulation of choice in continuous renal replacement therapy (CRRT). However, little is known about the pharmacokinetics (PKs) and metabolism of citrate in liver failure patients who require CRRT with regional citrate anticoagulation (RCA).

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Key information

Conditions

Citrate Toxicity Acute-On-Chronic Liver Failure Continuous Renal Replacement Therapy Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Liver Failure, Acute on Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacokinetic Regional Citrate Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn university

Bangkok, 10330, Thailand

About this study

This study aimed to evaluate citrate PKs, metabolic complications, and clinical outcomes among critically ill acute liver failure (ALF) and acute on top chronic liver failure (ACLF) patients receiving CRRT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Critically ill ALF or ACLF adult patients with AKI
  • aged ≥ 18 y old
  • Currently receiving CRRT.

Exclusion criteria

  • severe acidosis (pH < 7.1) or severe alkalosis (pH > 7.55)
  • blood transfusion within 24 h prior to the study
  • use of citrate-containing medications
  • severe hypocalcemia (serum ionized calcium < 0.8 mmol/L)
  • use of heparin as anticoagulation

Treatment and study plan

Pharmacokinetic study

Diagnostic Test
  • Start CVVH session with isotonic citrate solution (13.3 mmol/L) as predilution, targeting citrate dose at 3 mmol/L
  • Blood samples collection at pre-filter for citrate concentration, blood gas, electrolyte and ionized calcium and magnesium
  • In addition, 10 minutes after the end of citrate infusion, blood samples were taken simultaneously from both pre-filter and post-filter to calculate citrate clearance by filter

Primary outcomes

  1. Citrate clearance

    Time frame: 4 hours

    Citrate clearance by body

Secondary outcomes

  1. Citrate accumulation

    Time frame: 4 hours

    Number of total calcium to ionized calcium ratio > 2.5 with acidosis with hypocalcemia

  2. Tmax

    Time frame: 2 hours

    Time to maximum concentration of citrate at 2 hours

  3. Area under the time curve

    Time frame: 4 hours

    Area under the plasma concentration-time curve of citrate

  4. Change of systemic ionized calcium

    Time frame: 4 hours

    Change in systemic ionized calcium in arterial blood gas during study

  5. Change of ionized magnesium

    Time frame: 4 hours

    Change in systemic ionized magnesium in arterial blood gas during study

  6. Change of bicarbonate

    Time frame: 4 hours

    Change of bicarbonate in arterial blood gas during study

  7. Ratio of total calcium to systemic ionized calcium

    Time frame: 4 hours

    Number of patients with total calcium to systemic ionized calcium > 2.5 with or without metabolic acidosis

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Acronym: Citrate PK

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2021
Registry last updated
Nov 14, 2022

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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