Liver FailureNCT03791190
RCA for CRRT in Liver Failure and High Risk Bleeding Patients
A study testing Regional citrate anticoagulation and No-anticoagulation in people with Liver Failure, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure
- What is being tested?
- Regional citrate anticoagulation and No-anticoagulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2018to 30 Aug 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
- Liver failure (acute liver failure and chronic liver failure)
- High bleeding risk
- Scheduled CRRT treatment
- Informed consent
Who cannot join
- Use of other anticoagulants
- Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock
- Pregnancy or lactation
- Fistula, CRRT treatment time < 12 hours
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Nephrology
Xi'an, Shaanxi, 710032
Shiren Sun, M.D., +8602984775193, sunshiren@medmail.com.cn
Ming Bai, M.D., +8602984775193, mingbai1983@126.com
About this study
Official title: The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
Read the detailed description
Liver failure (LF) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (CRRT). Patients with LF are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO guideline recommended no-anticoagulation for CRRT in patients with liver failure and increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation CRRT. Several observational studies suggested that regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in patients with liver failure and high bleeding risk are controversial. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
- Conditions
- Liver Failure
- Being tested
- Regional citrate anticoagulation, No-anticoagulation
- Keywords
- CRRT, liver failure, filter lifespan, bleeding
- Medical subject headings
- Liver Failure, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional citrate anticoagulationOther
Also called RCA
Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
No-anticoagulationOther
Patients accepted CRRT without anticoagulant.
| Study group | Role | What they receive |
|---|---|---|
| No-anticoagulation | Active comparator | Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h. Receives: Other: No-anticoagulation |
| Regional citrate anticoagulation | Experimental | Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+.
Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level. Receives: Other: Regional citrate anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter failure
Filter failure
Measured: 72 hours
Secondary outcomes (9)
Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ ionized Ca2+ level
Measured: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Hypocalcemia
Ionized Ca2+ < 1.0
Measured: 72 hours
Acidosis
Blood pH < 7.35
Measured: 72 hours
Alkalosis
Blood pH > 7.45
Measured: 72 hours.
Bleeding
Bleeding episode during the CRRT.
Measured: 72 hours
Serum citrate concentration
Citrate concentration
Measured: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Serum total bilirubin level
Total bilirubin
Measured: Every 24 hours up to 72 hours.
Serum AST level
AST
Measured: Every 24 hours up to 72 hours.
Serum ALT level
ALT
Measured: Every 24 hours up to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start6 Sep 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
- Investigators
- Shiren Sun, Doctor, Study chair, Xijing Hospital, the Fourth Military Medical UniversityMing Bai, Doctor, Principal investigator, Xijing Hospital, the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791190
- Sponsor's protocol ID
- RCA for CRRT in liver failure
- Status last verified
- Dec 2018
- First submitted
- 12 Nov 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bai M, Yu Y, Zhao L, Tian X, Zhou M, Jiao J, Liu Y, Li Y, Yue Y, Wei L, Jing R, Li Y, Ma F, Liang Y, Sun S. Regional Citrate Anticoagulation versus No Anticoagulation for CKRT in Patients with Liver Failure with Increased Bleeding Risk. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):151-160. doi: 10.2215/CJN.0000000000000351. Epub 2023 Nov 6.
PubMed 37990929
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial
- ClinicalTrials.gov ID
- NCT03791190
- Acronym / sponsor ID
- RCA for CRRT in liver failure
- Conditions
- Liver Failure
- Keywords
- CRRT, liver failure, filter lifespan, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 2 Jan 2019 (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.
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
Detailed description
Liver failure (LF) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (CRRT). Patients with LF are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO guideline recommended no-anticoagulation for CRRT in patients with liver failure and increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation CRRT. Several observational studies suggested that regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in patients with liver failure and high bleeding risk are controversial. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-anticoagulation | Active comparator | Other: No-anticoagulationPatients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h. |
| Regional citrate anticoagulation | Experimental | Other: Regional citrate anticoagulationPatients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+. Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Liver failure (acute liver failure and chronic liver failure)
- High bleeding risk
- Scheduled CRRT treatment
- Informed consent
Key exclusion criteria (4 listed)
- Use of other anticoagulants
- Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock
- Pregnancy or lactation
- Fistula, CRRT treatment time < 12 hours
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 |
|---|---|---|
| Regional citrate anticoagulationAlso: RCASodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. | Other | Regional citrate anticoagulation |
| No-anticoagulationPatients accepted CRRT without anticoagulant. | Other | No-anticoagulation |
Primary outcome
Filter failure
Time frame: 72 hours
Filter failure
9 secondary outcomes
Serum Total Ca2+/ion Ca2+ level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Hypocalcemia
Time frame: 72 hours
Acidosis
Time frame: 72 hours
Alkalosis
Time frame: 72 hours.
Bleeding
Time frame: 72 hours
Serum citrate concentration
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
Serum total bilirubin level
Time frame: Every 24 hours up to 72 hours.
Serum AST level
Time frame: Every 24 hours up to 72 hours.
Serum ALT level
Time frame: Every 24 hours up to 72 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 37990929Bai M, Yu Y, Zhao L, Tian X, Zhou M, Jiao J, Liu Y, Li Y, Yue Y, Wei L, Jing R, Li Y, Ma F, Liang Y, Sun S. Regional Citrate Anticoagulation versus No Anticoagulation for CKRT in Patients with Liver Failure with Increased Bleeding Risk. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):151-160. doi: 10.2215/CJN.0000000000000351. Epub 2023 Nov 6.
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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.
Shiren Sun, Doctor study chair
Xijing Hospital, the Fourth Military Medical University
Ming Bai, Doctor principal investigator
Xijing Hospital, the Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional citrate anticoagulation and No-anticoagulation in people with Liver Failure, run by Air Force Military Medical University, China at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jan 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiren Sun, Doctor (+8602984775193, sunshiren@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter failure (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791190, which also lists 1 linked publication.
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 3 Jan 2019.