RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Liver Failure

Intervention / Treatment
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* Other: Regional citrate anticoagulation
* Other: No-anticoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver failure (acute liver failure and chronic liver failure) High bleeding risk Scheduled CRRT treatment Informed consent Exclusion Criteria: Use of other anticoagulants Uncorrectable hypoxemia (PaO2 < 60 mmHg) or systemic hypoperfusion shock Pregnancy or lactation Fistula, CRRT treatment time < 12 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No-anticoagulation<br>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. | Other: No-anticoagulation<br>* Patients accepted CRRT without anticoagulant.<br>|
| Experimental: Regional citrate anticoagulation<br>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. | Other: Regional citrate anticoagulation<br>* 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.<br>* Other names: RCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter failure | Filter failure | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Total Ca2+/ion Ca2+ level | Serum Total Ca2+/ ionized Ca2+ level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | 
| Hypocalcemia | Ionized Ca2+ < 1.0 | 72 hours | 
| Acidosis | Blood pH < 7.35 | 72 hours | 
| Alkalosis | Blood pH > 7.45 | 72 hours. | 
| Bleeding | Bleeding episode during the CRRT. | 72 hours | 
| Serum citrate concentration | Citrate concentration | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | 
| Serum total bilirubin level | Total bilirubin | Every 24 hours up to 72 hours. | 
| Serum AST level | AST | Every 24 hours up to 72 hours. | 
| Serum ALT level | ALT | Every 24 hours up to 72 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRRT, liver failure, filter lifespan, bleeding