Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 hyperlactatemia patients with increased bleeding risk.
For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reginal citrate anticoagulation | Experimental | Patients accepted regional citrate anticoagulation for CRRT. 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional citrate anticoagulation CRRT | Procedure | Regional citrate anticoagulation 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 | TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Ca2+/ion Ca2+ level | Serum Total Ca2+/ion Ca2+ level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours |
| Serum AST level | AST |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Bai, MD | Contact | +86029-84775197 | mingbai1983@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiren Sun, MD | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Nephrology | Xi'an | Shaanxi | 710032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065906 | Hyperlactatemia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No-anticoagulation CRRT | Procedure | Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution. |
|
| Every 24 hours up to 72 hours |
| Serum total bilirubin level | Total bilirubin | Every 24 hours up to 72 hours |
| Serum citrate concentration | Citrate concentration | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours |
| Serum lactate level | Serum lactate level | 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours |
| citrate accumulation | Metabolic acidosis with an increased anion gap, decreasing ionized calcium, elevated total calcium and the calcium ratio (totCa/ionCa) > 2.5 were considered as citrate accumulation. | 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 |
| APTT | activated partial thromboplastin time | Every 24 hours up to 72 hours |
| PT | Prothrombin time | Every 24 hours up to 72 hours |
| INR | International normalized ratio | Every 24 hours up to 72 hours |
| Mortality | In-hospital mortality | Up to 3 months |
| D010335 | Pathologic Processes |