Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

NCT ID: NCT04959110

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Citrate Toxicity Regional Citrate Anticoagulation Liver Failure, Acute Liver Failure, Acute on Chronic Pharmacokinetic Continuous Renal Replacement Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acute Liver Failure

Acute liver failure critically ill patients receiving CRRT

Group Type EXPERIMENTAL

Pharmacokinetic study

Intervention Type DIAGNOSTIC_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 on top Chronic Liver Failure

Acute on top chronic liver failure critically ill patients receiving CRRT

Group Type EXPERIMENTAL

Pharmacokinetic study

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Nattachai Srisawat ,M.D.

Director of Excellence Center for Critical Care Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chulalongkorn university

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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IRB.694/63

Identifier Type: -

Identifier Source: org_study_id

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