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

November 9, 2022 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acute Liver Failure
Acute liver failure critically ill patients receiving CRRT
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
EXPERIMENTAL: Acute on top Chronic Liver Failure
Acute on top chronic liver failure critically ill patients receiving CRRT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Citrate clearance
Time Frame: 4 hours
Citrate clearance by body
4 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.694/63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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