A CONTROLLED, RANDOMIZED CLINICAL TRIAL OF PERSONALIZED TWO-PHASE REGIONAL CITRATE ANTICOAGULATION IN PROLONGED INTERMITTENT KIDNEY REPLACEMENT THERAPY

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Abstract Title *

A CONTROLLED, RANDOMIZED CLINICAL TRIAL OF PERSONALIZED TWO-PHASE REGIONAL CITRATE ANTICOAGULATION IN PROLONGED INTERMITTENT KIDNEY REPLACEMENT THERAPY

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Co-author 1

Qi Zhang greenspring107@hotmail.com Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University Division of Nephrology Shanghai China *

Co-author 2

Xiao Bi bixiao0305@163.com Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University Division of Nephrology Shanghai China -

Co-author 3

Jun Ma mj11663@rjh.com.cn Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Division of Nephrology Shanghai China -

Co-author 4

Jun Xue xuejun@fudan.edu.cn Huashan Hospital, Fudan University Division of Nephrology Shanghai China -

Co-author 5

Yin Zheng zhengyin@huashan.org.cn Huashan Hospital, Fudan University Division of Nephrology Shanghai China -

Co-author 6

Chen Yu Yuchen@tongji.edu.cn Shanghai Tongji Hospital, Tongji University School of Medicine Division of Nephrology Shanghai China -

Co-author 7

Zhuxian Zhu Zhuzhuxian@126.com Shanghai Tongji Hospital, Tongji University School of Medicine Division of Nephrology Shanghai China -

Co-author 8

Jianxin Lu lujxswuu@126.com Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University Division of Nephrology Shanghai China -

Co-author 9

Leyi Gu guleyi@renji.com Renji Hospital, School of Medicine, Shanghai Jiaotong University Division of Nephrology Shanghai China -

Co-author 10

Weiming Zhang zhangweiming@renji.com Renji Hospital, School of Medicine, Shanghai Jiaotong University Division of Nephrology Shanghai China -

Co-author 11

Mingli Zhu millionzhu525@126.com Renji Hospital, School of Medicine, Shanghai Jiaotong University Division of Critical Care Medicine Shanghai China -

Co-author 12

Yining He ynhe@shsmu.edu.cn Shanghai Ninth People's Hospital, School of Medicine, Shanghai JiaoTong University Biostatistics Office of Clinical Research Unit Shanghai China -

Co-author 13

Xiaonong Chen cxn10419@rjh.com.cn Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Division of Nephrology Shanghai China -

Co-author 14

Feng Ding dingfeng@sjtu.edu.cn Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University Division of Nephrology Shanghai China -

Co-author 15

Introduction

This multicenter randomized controlled trial the safety and efficacy of personalized two-phase regional citrate anticoagulation (RCA) during prolonged intermittent kidney replacement therapy (PIKRT) in critically ill patients.

Methods

We conducted this study across five Chinese hospitals from December 2023 to April 2025. A total of 144 patients with acute or chronic kidney failure requiring PIKRT were randomized in a 1:1 ratio to receive either personalized RCA or conventional RCA using the Fresenius Ci-Ca protocol. The primary outcome was the non-intervention rate (proportion of measurements with post-filter ionized calcium 0.25-0.40 mmol/L and systemic ionized calcium 0.95-1.35 mmol/L).

Results

71 patients per group completed the study. The personalized two-phase RCA group achieved a higher non-intervention rate (96.9% vs 87.1%; p<0.01) and target attainment rate (78.4% vs 61.1%; p<0.01) with reduced hypocalcemia incidence (14.1% vs 50.7%; p<0.01, Table 1). Notably, 77.5% of intervention patients required no citrate or calcium adjustments versus 23.9% in controls (p<0.01), with personalized RCA demonstrating a two-phase calcium supplementation pattern that minimized ionized calcium fluctuations(Figure 1). Filter lifespan, circuit clotting grade, acid-base status and serum sodium levels showed no significant intergroup differences.Deviation rates for both citrate and calcium infusion consistently remained below 5%.

Conclusion

The pharmacokinetic-driven personalized two-phase RCA protocol demonstrates non-inferiority to conventional RCA controls, while exhibiting advantages in reducing intervention requirements and optimizing ionized calcium stability. Further validation of its clinical superiority requires large-scale multicenter randomized controlled trials.

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