Citrate ToxicityCitrate PKNCT04959110
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
A study testing Pharmacokinetic study in people with Citrate Toxicity and Regional Citrate Anticoagulation, run by Chulalongkorn University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Citrate Toxicity, Regional Citrate Anticoagulation, Liver Failure, Acute
- What is being tested?
- Pharmacokinetic study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill ALF or ACLF adult patients with AKI
- aged ≥ 18 y old
- Currently receiving CRRT.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Citrate Toxicity, Regional Citrate Anticoagulation, Liver Failure, Acute, Liver Failure, Acute on Chronic, Pharmacokinetic, Continuous Renal Replacement Therapy
- Being tested
- Pharmacokinetic study
- Keywords
- Regional citrate anticoagulation, Liver failure, Pharmacokinetics, CRRT, Cirrhosis
- Medical subject headings
- Liver Failure, Acute, Acute-On-Chronic Liver Failure, Liver Failure, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Acute Liver Failure | Experimental | Acute liver failure critically ill patients receiving CRRT Receives: Diagnostic Test: Pharmacokinetic study |
| Acute on top Chronic Liver Failure | Experimental | Acute on top chronic liver failure critically ill patients receiving CRRT Receives: Diagnostic Test: Pharmacokinetic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrate clearance
Citrate clearance by body
Measured: 4 hours
Secondary outcomes (7)
Citrate accumulation
Number of total calcium to ionized calcium ratio > 2.5 with acidosis with hypocalcemia
Measured: 4 hours
Tmax
Time to maximum concentration of citrate at 2 hours
Measured: 2 hours
Area under the time curve
Area under the plasma concentration-time curve of citrate
Measured: 4 hours
Change of systemic ionized calcium
Change in systemic ionized calcium in arterial blood gas during study
Measured: 4 hours
Change of ionized magnesium
Change in systemic ionized magnesium in arterial blood gas during study
Measured: 4 hours
Change of bicarbonate
Change of bicarbonate in arterial blood gas during study
Measured: 4 hours
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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Citrate ToxicityStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959110
- Sponsor's protocol ID
- IRB.694/63
- Acronym
- Citrate PK
- Status last verified
- Nov 2022
- First submitted
- 9 Jun 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
- ClinicalTrials.gov ID
- NCT04959110
- Acronym / sponsor ID
- Citrate PK / IRB.694/63
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Liver Failure | Experimental | Diagnostic Test: Pharmacokinetic studyAcute liver failure critically ill patients receiving CRRT |
| Acute on top Chronic Liver Failure | Experimental | Diagnostic Test: Pharmacokinetic studyAcute on top chronic liver failure critically ill patients receiving CRRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critically ill ALF or ACLF adult patients with AKI
- aged ≥ 18 y old
- Currently receiving CRRT.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Acute Liver Failure, Acute on top Chronic Liver Failure |
Primary outcome
Citrate clearance
Time frame: 4 hours
Citrate clearance by body
7 secondary outcomes
Citrate accumulation
Time frame: 4 hours
Tmax
Time frame: 2 hours
Area under the time curve
Time frame: 4 hours
Change of systemic ionized calcium
Time frame: 4 hours
Change of ionized magnesium
Time frame: 4 hours
Change of bicarbonate
Time frame: 4 hours
Ratio of total calcium to systemic ionized calcium
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic study in people with Citrate Toxicity and Regional Citrate Anticoagulation, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citrate clearance (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.