NCT04959110

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.5 years

First QC Date

June 9, 2021

Last Update Submit

November 9, 2022

Conditions

Citrate ToxicityRegional Citrate AnticoagulationLiver Failure, AcuteLiver Failure, Acute on ChronicPharmacokineticContinuous Renal Replacement Therapy

Keywords

Regional citrate anticoagulationLiver failurePharmacokineticsCRRTCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Citrate clearance

    Citrate clearance by body

    4 hours

Secondary Outcomes (7)

  • Citrate accumulation

    4 hours

  • Tmax

    2 hours

  • Area under the time curve

    4 hours

  • Change of systemic ionized calcium

    4 hours

  • Change of ionized magnesium

    4 hours

  • +2 more secondary outcomes

Study Arms (2)

Acute Liver Failure

EXPERIMENTAL

Acute liver failure critically ill patients receiving CRRT

Diagnostic Test: Pharmacokinetic study

Acute on top Chronic Liver Failure

EXPERIMENTAL

Acute on top chronic liver failure critically ill patients receiving CRRT

Diagnostic Test: Pharmacokinetic study

Interventions

Pharmacokinetic studyDIAGNOSTIC_TEST

* 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

Acute Liver FailureAcute on top Chronic Liver Failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill ALF or ACLF adult patients with AKI
  • aged ≥ 18 y old
  • Currently receiving CRRT.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn university

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Liver Failure, AcuteAcute-On-Chronic Liver FailureLiver FailureFibrosis

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Excellence Center for Critical Care Nephrology

Study Record Dates

First Submitted

June 9, 2021

First Posted

July 13, 2021

Study Start

July 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

TH(1)