Thanapongsatorn Peerapat, Sinjira Tanyapim, Kaewdoungtien Piyanut, Kusirisin Prit, Kulvichit Win, Sirivongrangson Phatadon, Peerapornratana Sadudee, Lumlertgul Nuttha, Srisawat Nattachai
Department of Medicine, Central Chest Institute of Thailand, Nonthaburi, Thailand.
Excellence Center for Critical Care Nephrology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Clin Kidney J. 2023 Mar 31;16(9):1469-1479. doi: 10.1093/ckj/sfad069. eCollection 2023 Sep.
Current guidelines recommend monitoring of post-filter ionized calcium (pfCa) when using regional citrate anticoagulation during continuous renal replacement therapy (RCA-CRRT) to determine citrate efficiency for the prevention of filter clotting. However, the reliability of pfCa raises the question of whether routine monitoring is required. Reducing the frequency of pfCa monitoring could potentially reduce costs and workload. Our objective was to test the efficacy and safety of no pfCa monitoring among critically ill patients receiving RCA-CRRT.
This study was a non-inferiority randomized controlled trial conducted between January 2021 and October 2021 at King Chulalongkorn Memorial Hospital, Thailand. Critically ill patients who were treated with RCA-CRRT were randomized to receive either standard pfCa monitoring (aiming pfCa level of 0.25-0.35 mmol/L), or no pfCa monitoring, in which a constant rate of citrate infusion was maintained at pre-determined citrate concentrations of 4 mmol/L with blinding of pfCa levels to treating clinicians. The primary outcome was the filter lifespan. Non-inferiority would be demonstrated if the upper limit of the 95% confidence interval (CI) for the difference in filter lifespan between the groups was less than 20 h.
Fifty patients were randomized to the standard pfCa monitoring group ( = 25) or no pfCa monitoring group ( = 25). The mean filter lifespan was 54 ± 20 h in the standard pfCa monitoring group and 47 ± 23 h in the no pfCa monitoring group (absolute difference 7.1 h; 95% CI -5.3, 19.5, = .25). When restricting the analysis to circuits reaching the maximum duration of circuit lifespan at 72 h and clotted filters, the filter lifespan was 61 ± 17 h in the standard pfCa group vs 60 ± 19 h in the no pfCa monitoring group (absolute difference 0.9 h; 95% CI -11.5, 13.4, = .88). Compared with the no pfCa monitoring group, the standard pfCa monitoring group had a significantly higher mean citrate concentrations (4.43 ± 0.32 vs 4 mmol/L, < .001) and a higher rate of severe hypocalcemia (44% vs 20%, = .13). No statistical differences were found in filter clotting, citrate accumulation, citrate overload and mortality between the two groups.
Among critically ill patients receiving RCA-CRRT, no pfCa monitoring by maintaining the citrate concentrations of 4 mmol/L is feasible. Larger randomized controlled trials should be conducted to ensure the efficacy, safety and cost-effectiveness of this strategy.
ClinicalTrials.gov: NCT04792424 (registered 11 March 2021).
当前指南建议在连续性肾脏替代治疗(RCA-CRRT)期间使用局部枸橼酸抗凝时监测滤器后离子钙(pfCa),以确定枸橼酸预防滤器凝血的效果。然而,pfCa的可靠性引发了是否需要常规监测的问题。减少pfCa监测频率可能会降低成本和工作量。我们的目的是测试在接受RCA-CRRT的重症患者中不进行pfCa监测的有效性和安全性。
本研究是一项非劣效性随机对照试验,于2021年1月至2021年10月在泰国朱拉隆功国王纪念医院进行。接受RCA-CRRT治疗的重症患者被随机分为接受标准pfCa监测(目标pfCa水平为0.25 - 0.35 mmol/L)或不进行pfCa监测两组,后者以4 mmol/L的预定枸橼酸浓度维持恒定的枸橼酸输注速率,且向治疗医生隐瞒pfCa水平。主要结局是滤器使用寿命。如果两组滤器使用寿命差异的95%置信区间(CI)上限小于20小时,则表明具有非劣效性。
50例患者被随机分为标准pfCa监测组(n = 25)和不进行pfCa监测组(n = 25)。标准pfCa监测组的平均滤器使用寿命为54 ± 20小时,不进行pfCa监测组为47 ± 23小时(绝对差异7.1小时;95% CI -5.3, 19.5,P = 0.25)。当将分析限制在达到72小时的最大回路使用寿命和已凝血滤器的回路时,标准pfCa组的滤器使用寿命为61 ± 17小时,不进行pfCa监测组为60 ± 19小时(绝对差异0.9小时;95% CI -11.5, 13.4,P = 0.88)。与不进行pfCa监测组相比,标准pfCa监测组的平均枸橼酸浓度显著更高(4.43 ± 0.32 vs 4 mmol/L,P < 0.001),严重低钙血症发生率也更高(44% vs 20%,P = 0.13)。两组在滤器凝血、枸橼酸蓄积、枸橼酸过载和死亡率方面未发现统计学差异。
在接受RCA-CRRT的重症患者中,通过维持4 mmol/L的枸橼酸浓度不进行pfCa监测是可行的。应进行更大规模的随机对照试验以确保该策略的有效性、安全性和成本效益。
ClinicalTrials.gov:NCT04792424(于2021年3月11日注册)