Pharmacokinetic Clinical Trial
— Citrate PKOfficial title:
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
Verified date | November 2022 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Chulalongkorn university | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
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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