Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Chulalongkorn University20 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

Pharmacokinetic studyDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chulalongkorn university

Bangkok, Thailand

Outcomes

Primary Outcomes

Citrate clearance

Citrate clearance by body

Time frame: 4 hours

Secondary Outcomes

Citrate accumulation

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

Time frame: 4 hours

Tmax

Time to maximum concentration of citrate at 2 hours

Time frame: 2 hours

Area under the time curve

Area under the plasma concentration-time curve of citrate

Time frame: 4 hours

Change of systemic ionized calcium

Change in systemic ionized calcium in arterial blood gas during study

Time frame: 4 hours

Change of ionized magnesium

Change in systemic ionized magnesium in arterial blood gas during study

Time frame: 4 hours

Change of bicarbonate

Change of bicarbonate in arterial blood gas during study

Time frame: 4 hours

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

Data from ClinicalTrials.gov

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