| 초록 |
Objectives: Continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA) requires precise ionized calcium (iCa) monitoring to ensure circuit patency and patient safety. Standard post-filter iCa measurement necessitates frequent blood sampling, contributing to iatrogenic anemia and increased nursing workload. Effluent fluid iCa monitoring represents a novel, bloodless alternative. This trial aimed to evaluate whether effluent iCa monitoring is non-inferior to standard post-filter monitoring for guiding RCA in critically ill patients. Methods: We conducted a single-center, randomized controlled non-inferiority trial at West China Hospital of Sichuan University. A total of 76 critically ill patients requiring CRRT-RCA were randomly assigned in a 1:1 ratio to anticoagulation guided by effluent fluid iCa (intervention group; target 0.2–0.4 mmol/L) or standard post-filter iCa (control group; target 0.25–0.35 mmol/L). The primary outcome was filter lifespan, with a pre-specified non-inferiority margin of –4.8 hours. Secondary outcomes included circuit clotting scores, metabolic complications (hypocalcemia, alkalosis, acidosis), citrate accumulation, and blood loss. Analysis was performed by intention-to-treat. Results: The median filter lifespan was 66.9 hours (IQR, 42 to 72) in the effluent group and 70.0 hours (IQR, 52 to 72) in the post-filter group. The mean difference in filter lifespan was 3.96 hours (one-sided 95% CI, 4.72), confirming non-inferiority as the upper confidence limit did not exceed the –4.8-hour margin. The 72-hour circuit survival rate was similar between groups (55.3% vs. 57.9%, p=0.82). Safety profiles were comparable: hypocalcemia occurred in 8.2% vs. 7.6% (p=0.72), metabolic alkalosis in 4.3% vs. 4.8% (p=0.81), and citrate accumulation in 2.1% vs. 2.4% (p=0.88) for the effluent and post-filter groups, respectively. Conclusion: Effluent fluid iCa monitoring is non-inferior to standard post-filter monitoring for managing RCA during CRRT. This bloodless strategy effectively maintains circuit patency without increasing metabolic complications, offering a safe, cost-effective alternative that reduces iatrogenic blood loss and nursing workload. |