Liver Failure Clinical Trial
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital of Nephrology | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Filter failure | Filter failure | 72 hours | |
Secondary | Serum Total Ca2+/ion Ca2+ level | Serum Total Ca2+/ ionized Ca2+ level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | |
Secondary | Hypocalcemia | Ionized Ca2+ < 1.0 | 72 hours | |
Secondary | Acidosis | Blood pH < 7.35 | 72 hours | |
Secondary | Alkalosis | Blood pH > 7.45 | 72 hours. | |
Secondary | Bleeding | Bleeding episode during the CRRT. | 72 hours | |
Secondary | Serum citrate concentration | Citrate concentration | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours. | |
Secondary | Serum total bilirubin level | Total bilirubin | Every 24 hours up to 72 hours. | |
Secondary | Serum AST level | AST | Every 24 hours up to 72 hours. | |
Secondary | Serum ALT level | ALT | Every 24 hours up to 72 hours. |
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