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CompletedNCT04959110Citrate PKUpdated Nov 14, 2022

Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

An interventional study of Pharmacokinetic study in Citrate Toxicity, Regional Citrate Anticoagulation and Liver Failure, Acute, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jul 2019, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Citrate Toxicity
  • Regional Citrate Anticoagulation
  • Liver Failure, Acute
  • Liver Failure, Acute on Chronic
  • Pharmacokinetic
  • Continuous Renal Replacement Therapy

Keywords

  • Regional citrate anticoagulation
  • Liver failure
  • Pharmacokinetics
  • CRRT
  • Cirrhosis
03

In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's enrollment of 20 is below the median of 43 across 276 interventional studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Acute Liver Failure

    Acute liver failure critically ill patients receiving CRRT

    Diagnostic Test: Pharmacokinetic study

  • Experimental
    Acute on top Chronic Liver Failure

    Acute on top chronic liver failure critically ill patients receiving CRRT

    Diagnostic Test: Pharmacokinetic study

Interventions

  • Diagnostic testPharmacokinetic study

    * 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

06

What researchers measure

Primary outcomes

  1. Citrate clearance

    Citrate clearance by body

    Time frame: 4 hours

Secondary outcomes

  1. Citrate accumulation

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

    Time frame: 4 hours

  2. Tmax

    Time to maximum concentration of citrate at 2 hours

    Time frame: 2 hours

  3. Area under the time curve

    Area under the plasma concentration-time curve of citrate

    Time frame: 4 hours

  4. Change of systemic ionized calcium

    Change in systemic ionized calcium in arterial blood gas during study

    Time frame: 4 hours

  5. Change of ionized magnesium

    Change in systemic ionized magnesium in arterial blood gas during study

    Time frame: 4 hours

  6. Change of bicarbonate

    Change of bicarbonate in arterial blood gas during study

    Time frame: 4 hours

  7. Ratio of total calcium to systemic ionized calcium

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

    Time frame: 4 hours

07

Study locations

1 site
  • Chulalongkorn university
    Bangkok, 10330, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04959110
Lead sponsor
Chulalongkorn University
Responsible party
Nattachai Srisawat ,M.D. (Director of Excellence Center for Critical Care Nephrology, Chulalongkorn University) — Principal investigator
First posted
Jul 13, 2021
Start date
Jul 1, 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Nov 14, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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