Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Not Applicable

Completed

• Conditions: Citrate Toxicity; Liver Failure, Acute on Chronic; Continuous Renal Replacement Therapy; Regional Citrate Anticoagulation; Liver Failure, Acute; Pharmacokinetic
• Interventions: Diagnostic Test: Pharmacokinetic study

• Registration Number: NCT04959110
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-13
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute Liver Failure	Pharmacokinetic study	Acute liver failure critically ill patients receiving CRRT
Acute on top Chronic Liver Failure	Pharmacokinetic study	Acute on top chronic liver failure critically ill patients receiving CRRT

Primary Outcome Measures

Name	Time	Method
Citrate clearance	4 hours	Citrate clearance by body

Secondary Outcome Measures

Name	Time	Method
Tmax	2 hours	Time to maximum concentration of citrate at 2 hours
Area under the time curve	4 hours	Area under the plasma concentration-time curve of citrate
Citrate accumulation	4 hours	Number of total calcium to ionized calcium ratio \> 2.5 with acidosis with hypocalcemia
Change of systemic ionized calcium	4 hours	Change in systemic ionized calcium in arterial blood gas during study
Change of ionized magnesium	4 hours	Change in systemic ionized magnesium in arterial blood gas during study
Change of bicarbonate	4 hours	Change of bicarbonate in arterial blood gas during study
Ratio of total calcium to systemic ionized calcium	4 hours	Number of patients with total calcium to systemic ionized calcium \> 2.5 with or without metabolic acidosis

Trial Locations

Locations (1)

Chulalongkorn university; 🇹🇭 Bangkok, Thailand