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Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT (Citrate PK)

Primary Purpose

Citrate Toxicity, Regional Citrate Anticoagulation, Liver Failure, Acute

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pharmacokinetic study
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Citrate Toxicity focused on measuring Regional citrate anticoagulation, Liver failure, Pharmacokinetics, CRRT, Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chulalongkorn university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acute Liver Failure

Acute on top Chronic Liver Failure

Arm Description

Acute liver failure critically ill patients receiving CRRT

Acute on top chronic liver failure critically ill patients receiving CRRT

Outcomes

Primary Outcome Measures

Citrate clearance
Citrate clearance by body

Secondary Outcome Measures

Citrate accumulation
Number of total calcium to ionized calcium ratio > 2.5 with acidosis with hypocalcemia
Tmax
Time to maximum concentration of citrate at 2 hours
Area under the time curve
Area under the plasma concentration-time curve of citrate
Change of systemic ionized calcium
Change in systemic ionized calcium in arterial blood gas during study
Change of ionized magnesium
Change in systemic ionized magnesium in arterial blood gas during study
Change of bicarbonate
Change of bicarbonate in arterial blood gas during study
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

Full Information

First Posted
June 9, 2021
Last Updated
November 9, 2022
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04959110
Brief Title
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
Acronym
Citrate PK
Official Title
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Citrate Toxicity, Regional Citrate Anticoagulation, Liver Failure, Acute, Liver Failure, Acute on Chronic, Pharmacokinetic, Continuous Renal Replacement Therapy
Keywords
Regional citrate anticoagulation, Liver failure, Pharmacokinetics, CRRT, Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Liver Failure
Arm Type
Experimental
Arm Description
Acute liver failure critically ill patients receiving CRRT
Arm Title
Acute on top Chronic Liver Failure
Arm Type
Experimental
Arm Description
Acute on top chronic liver failure critically ill patients receiving CRRT
Intervention Type
Diagnostic Test
Intervention Name(s)
Pharmacokinetic study
Intervention Description
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
Primary Outcome Measure Information:
Title
Citrate clearance
Description
Citrate clearance by body
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Citrate accumulation
Description
Number of total calcium to ionized calcium ratio > 2.5 with acidosis with hypocalcemia
Time Frame
4 hours
Title
Tmax
Description
Time to maximum concentration of citrate at 2 hours
Time Frame
2 hours
Title
Area under the time curve
Description
Area under the plasma concentration-time curve of citrate
Time Frame
4 hours
Title
Change of systemic ionized calcium
Description
Change in systemic ionized calcium in arterial blood gas during study
Time Frame
4 hours
Title
Change of ionized magnesium
Description
Change in systemic ionized magnesium in arterial blood gas during study
Time Frame
4 hours
Title
Change of bicarbonate
Description
Change of bicarbonate in arterial blood gas during study
Time Frame
4 hours
Title
Ratio of total calcium to systemic ionized calcium
Description
Number of patients with total calcium to systemic ionized calcium > 2.5 with or without metabolic acidosis
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chulalongkorn university
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

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