含钙与不含钙的置换液在局部枸橼酸抗凝连续性肾脏替代治疗中的应用：一项随机对照试验。

Calcium-containing versus calcium-free replacement solution in regional citrate anticoagulation for continuous renal replacement therapy: a randomized controlled trial.

机构信息

Department of Nephrology, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China.

出版信息

Chin Med J (Engl). 2022 Oct 20;135(20):2478-2487. doi: 10.1097/CM9.0000000000002369.

DOI:10.1097/CM9.0000000000002369

PMID:36583864

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9945286/

Abstract

BACKGROUND

A simplified protocol for regional citrate anticoagulation (RCA) using a commercial calcium-containing replacement solution, without continuous calcium infusion, is more efficient for use in continuous renal replacement therapy (CRRT). We aim to design a randomized clinical trial to compare the safety and efficacy between calcium-free and calcium-containing replacement solutions in CRRT with RCA.

METHODS

Of the 64 patients receiving RCA-based postdilution continuous venovenous hemodiafiltration (CVVHDF) enrolled from 2017 to 2019 in West China Hospital of Sichuan University, 35 patients were randomized to the calcium-containing group and 29 to the calcium-free replacement solution group. The primary endpoint was circuit lifespan and Kaplan-Meier survival analysis was performed. Secondary endpoints included hospital mortality, kidney function recovery rate, and complications. The amount of 4% trisodium citrate solution infusion was recorded. Serum and effluent total (tCa) and ionized (iCa) calcium concentrations were measured during CVVHDF.

RESULTS

A total of 149 circuits (82 in the calcium-containing group and 67 in the calcium-free group) and 7609 circuit hours (4335 h vs. 3274 h) were included. The mean circuit lifespan was 58.1 h (95% CI 53.8-62.4 h) in the calcium-containing group vs. 55.3 h (95% CI 49.7-60.9 h, log rank P = 0.89) in the calcium-free group. The serum tCa and iCa concentrations were slightly lower in the calcium-containing group during CRRT, whereas the postfilter iCa concentration was lower in the calcium-free group. Moreover, the mean amounts of 4% trisodium citrate solution infusion were not significantly different between the groups (171.1 ± 15.9 mL/h vs. 169.0 ± 15.1 mL/h, P = 0.49). The mortality (14/35 [40%] vs. 13/29 [45%], P = 0.70) and kidney function recovery rates of AKI patients (19/26, 73% vs. 14/24, 58%, P = 0.27) were comparable between the calcium-containing and calcium-free group during hospitalization, respectively. Six (three in each group) patients showed signs of citrate accumulation in this study.

CONCLUSIONS

When compared with calcium-free replacement solution, RCA-based CVVHDF with calcium-containing replacement solution had a similar circuit lifespan, hospital mortality and kidney outcome. Since the calcium-containing solution obviates the need for a separate venous catheter and a large dose of intravenous calcium solution preparation for continuous calcium supplementation, it is more convenient to be applied in RCA-CRRT practice.

REGISTRATION

Chinese Clinical Trial Registry (www.chictr.org.cn, ChiCTR-IPR-17012629).

摘要

背景

使用含有商业钙的替代溶液，不连续输注钙，简化了局部枸橼酸抗凝（RCA）方案，更有利于连续性肾脏替代治疗（CRRT）的应用。我们旨在设计一项随机临床试验，比较 RCA-CRRT 中无钙和含钙替代溶液的安全性和疗效。

方法

2017 年至 2019 年，在四川大学华西医院接受 RCA 后稀释连续性静脉-静脉血液透析滤过（CVVHDF）的 64 例患者中，35 例随机分为含钙组，29 例分为无钙替代溶液组。主要终点是回路寿命，采用 Kaplan-Meier 生存分析。次要终点包括住院死亡率、肾功能恢复率和并发症。记录 4%三钠枸橼酸溶液的输注量。在 CVVHDF 期间，测量血清和流出液总（tCa）和离子（iCa）钙浓度。

结果

共纳入 149 个回路（含钙组 82 个，无钙组 67 个）和 7609 个回路小时（4335 小时比 3274 小时）。含钙组的平均回路寿命为 58.1 小时（95%CI 53.8-62.4 小时），无钙组为 55.3 小时（95%CI 49.7-60.9 小时，对数秩 P=0.89）。CRRT 期间，含钙组血清 tCa 和 iCa 浓度略低，而无钙组滤后 iCa 浓度较低。此外，两组间 4%三钠枸橼酸溶液的平均输注量无显著差异（171.1±15.9 mL/h 比 169.0±15.1 mL/h，P=0.49）。住院期间，含钙组和无钙组 AKI 患者的死亡率（14/35 [40%] 比 13/29 [45%]，P=0.70）和肾功能恢复率（19/26，73%比 14/24，58%，P=0.27）相似。本研究中有 6 例（每组 3 例）患者出现枸橼酸盐蓄积迹象。