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Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04959110
Acronym
Citrate PK
Enrollment
20
Registered
2021-07-13
Start date
2019-07-01
Completion date
2021-12-31
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Regional citrate anticoagulation, Liver failure, Pharmacokinetics, CRRT, Cirrhosis

Brief 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).

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.

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

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Citrate clearance4 hoursCitrate clearance by body

Secondary

MeasureTime frameDescription
Citrate accumulation4 hoursNumber of total calcium to ionized calcium ratio \> 2.5 with acidosis with hypocalcemia
Tmax2 hoursTime to maximum concentration of citrate at 2 hours
Area under the time curve4 hoursArea under the plasma concentration-time curve of citrate
Ratio of total calcium to systemic ionized calcium4 hoursNumber of patients with total calcium to systemic ionized calcium \> 2.5 with or without metabolic acidosis
Change of ionized magnesium4 hoursChange in systemic ionized magnesium in arterial blood gas during study
Change of bicarbonate4 hoursChange of bicarbonate in arterial blood gas during study
Change of systemic ionized calcium4 hoursChange in systemic ionized calcium in arterial blood gas during study

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026