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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional citrate anticoagulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Filter failure | Filter failure | 72 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiren Sun, Doctor | Contact | +8602984775193 | sunshiren@medmail.com.cn | |
| Ming Bai, Doctor | Contact | sunshiren@medmail.com.cn | mingbai1983@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiren Sun, Doctor | Xijing Hospital, the Fourth Military Medical University | Study Chair |
| Ming Bai, Doctor | Xijing Hospital, the Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Nephrology | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37990929 | Derived | 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. |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
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|
| No-anticoagulation | Other | Patients accepted CRRT without anticoagulant. |
|
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |