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NCT04959110 Clinical Trial

Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Pharmacokinetic Clinical Trial

— Citrate PK  

Official title:
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04959110
Other study ID # IRB.694/63
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2021

Study information
Verified date November 2022
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pharmacokinetic 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

Locations
Country Name City State
Thailand Chulalongkorn university Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Citrate clearance Citrate clearance by body 4 hours
Secondary Citrate accumulation Number of total calcium to ionized calcium ratio > 2.5 with acidosis with hypocalcemia 4 hours
Secondary Tmax Time to maximum concentration of citrate at 2 hours 2 hours
Secondary Area under the time curve Area under the plasma concentration-time curve of citrate 4 hours
Secondary Change of systemic ionized calcium Change in systemic ionized calcium in arterial blood gas during study 4 hours
Secondary Change of ionized magnesium Change in systemic ionized magnesium in arterial blood gas during study 4 hours
Secondary Change of bicarbonate Change of bicarbonate in arterial blood gas during study 4 hours
Secondary 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 4 hours
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